New meta-analysis finds six month follow-ups miss quarter of visceral leishmaniasis relapses
07 Dec 2023
A meta-analysis of nearly 30,000 patients suggests that a post-treatment follow-up duration of longer than 6-months may be needed to identify visceral leishmaniasis relapses.
Visceral Leishmaniasis (also known as Kala Azar across the Indian subcontinent) is a protozoan parasitic disease which causes fever, weight loss, fatigue and anaemia. It is fatal in over 95% of the untreated cases, but the right treatment significantly reduces deaths and disease effects.
However, relapses after treatment, with clinical symptoms returning months later, remains a major public health concern. Quantifying these relapses is important to control the spread of the disease, so IDDO researchers in collaborations with colleagues working in the field undertook a large scale meta-analysis to generate a baseline estimate of relapses in patients who have been treated.
The research team used the Infectious Diseases Data Observatory (IDDO)’s library of visceral leishmaniasis clinical studies: this library is a living systematic review updated on a periodic basis to indicate relevant publications indexed by major research databases in the field.
“We extracted data from the studies indexed in the IDDO’s library of visceral leishmaniasis clinical studies and analysed them to estimate the proportion of patients who showed signs of the disease returning after treatment had been completed,” said IDDO’s Dr Prabin Dahal, one of the study authors.
This analysis found that the rates of relapse varied widely, depending on where the patients lived and the exact drug regiment used for the treatment – between 0.5% and 4.5% of patients in the Indian subcontinent showed signs of the disease returning, but for East Africa, as many as 13% of the treated patients had recurring symptoms.
“Patients were also less likely to relapse after treatment with a combination of drugs, rather than single drug”, said IDDO’s Rutuja Chhajed, the study’s first author. The study also highlights previous work suggesting that a combination of drugs might work synergistically to reduce relapse rates as well as treatment duration for visceral leishmaniasis treatment, potentially helping to alleviate the burden on healthcare systems.
“21 of the studies we analysed followed up patients for longer than the standard six months, and based on these studies, we estimate that more than 27% of the relapses were being missed in the six month follow up,” said Dr Prabin Dahal. “Prompt identification and treatment of relapsing visceral leishmaniasis remains priority for the Kala Azar elimination programme in the Indian subcontinent and other regions as they provide an infective pool of the parasite to fuel disease transmission. We think that a longer follow-up duration is needed in future studies of visceral leishmaniasis to capture the late relapses, which remains crucial for disease control”.
Read the full paper in the Lancet Regional Health - SouthEast Asia.
Find out more about our work on Visceral Leishmaniasis, and access our free database.
Join IDDO’s team at ECTMIH 2023
09 Nov 2023
IDDO and WWARN are delighted to be taking part in this year’s 13th European Congress on Tropical Medicine and International Health, (ECTMIH), and will be sharing our latest research across visceral leishmaniasis, malaria, medicine quality and lymphatic filariasis.
This year’s meeting, in Utrecht, will focus on shaping the future of equitable and sustainable planetary health.
IDDO’s researchers will be presenting our latest research at a series of oral presentations and via e-posters.
Oral presentations
Tuesday, November 21
Join IDDO’s team at Tivoli Vredenburg Cloud Nine Track 2, from 10:30am (Central European Time CET), for a presentation on 'Safety and efficacy of primaquine in patients with P. vivax malaria from South Asia: A systematic review and individual patient data meta-analysis'
Thursday, November 23
Watch two presentations on visceral leishmaniasis on, at the Social Impact Factory Room 3, from 10.30am CET
- Host, parasite and drug determinants of treatment outcomes in Visceral Leishmaniasis: An individual patient data meta-analysis using the Infectious Diseases Data Observatory data platform
- Haemoglobin dynamics following treatment of Visceral Leishmaniasis: An individual patient data meta-analysis using the Infectious Diseases Data Observatory data platform
Join IDDO at 3.30pm CET in the Tivoli Vredenburg Hertz, Track 2, for our presentation ‘Systematic review and geospatial modelling of molecular markers of resistance to artemisinins and sulfadoxine-pyrimethamine in Plasmodium falciparum in India'
Posters
- Ophthalmological Complications in Visceral Leishmaniasis and Post Kala-Azar Dermal Leishmaniasis: A Systematic Review of Published Literature
- Lymphatic filariasis treatment studies: the case for an individual participant-level data platform
- Navigating the Neglected Crystal Ball: A Systematic Review of Prognostic Models in Visceral Leishmaniasis
- Substandard and falsified vaccines and their detection
ECTMIH, which takes place from November 23 to 23, provides a platform for experts, scientists and researchers to present scientific developments and breakthroughs in tropical medicine and global health, and strengthens networks and creates new partnerships.
If you are not able to join us in-person then why not follow what is happening at the conference over Twitter by following us on @IDDOnews
Read our latest news or email info@iddo.org with your questions.
IDDO and WWARN Director receives ASTMH medal
20 Oct 2023
Professor Philippe Guérin, IDDO and WWARN’s Director, has been awarded the Bailey K. Ashford Medal for his “distinguished” work in tropical medicine.
The American Society for Tropical Medicine and Hygiene (ASTMH ) President Daniel G. Bausch presented the medal at a ceremony at the Hyatt Regency Chicago, on the opening day of the 72nd annual meeting of the society
Professor Guérin was nominated for the award by Dr Abib Abera, of Addis Ababa University (AAU), Ethiopia, to mark his 25-year career in the field of tropical medicine where he has led research in clinical trials and epidemiology to improve outcomes for some of the world’s most vulnerable populations.
He began his career as a physician working in France and Nepal, before joining Médecins Sans Frontières where he worked in the field in many countries in Africa and Asia. He later moved into research and held a number of posts with the Wellcome Trust Oxford Research Unit in Thailand, the Department of Infectious Disease Epidemiology at the Norwegian Institute of Public Health, and Épicentre in Paris - a World Health Organization (WHO) Collaborating Centre for Research in epidemiology and response to emerging diseases.
Philippe’s interest lay in research and how data could be better used to further research. He has been the director of the WorldWide Antimalarial Network (WWARN) since its inception. WWARN is a collaborative data platform generating innovative resources and reliable evidence to inform the malaria community on the factors affecting the efficacy of antimalarial medicines. In 2016, Philippe established the Infectious Diseases Data Observatory (IDDO), focusing on neglected tropical diseases and emerging infections to provide an environment for equitable sharing of data, methods and infrastructure to generate evidence that improves outcomes for patients worldwide.
The Bailey K. Ashford Medal is named in honour of Bailey K. Ashford who recognised the connection between hookworm infection and anaemia at the age of 26.
Philippe said “I am thrilled to be awarded this medal, which is more of a recognition of the hard work of the very many people I have worked with throughout my career.”
Dr
Farhad
Shokraneh
Evidence Synthesis Manager
Research Theme
Malaria
Visceral leishmaniasis
COVID19
Schistosomiasis & STHs
Chagas
WWARN
Dr Farhad Shokraneh has 20 years of experience and a PhD in Evidence Synthesis. He joined IDDO in October 2023 as Evidence Synthesis Manager.
Previously, he has worked at the University of Nottingham, King's College London, University College London, UCLH, and Cambridge University in similar roles. He has led teams to deliver projects to clients such as WHO, UN, UNICEF, FDA, UK NIHR, Cochrane, AWMF, and NICE.
As a passionate methodologist and change maker, Farhad is a co-author of the Cochrane Handbook, an editor of Systematic Reviews journal and has designed the first and most sensitive search strategy for COVID-19 literature and the first living search strategy and coined concepts such as 'Search-Resistant Concepts', 'Search Pyramid', 'Living Search Strategy', and 'Iterative Systematic Reviews'.
Dr
Charvy
Narain
Communications Manager
Email
Research Theme
Malaria
Visceral leishmaniasis
COVID19
Schistosomiasis & STHs
Chagas
Medicine quality
Antimicrobial resistance
WWARN
Dr Charvy Narain holds a doctorate in Neurosciences from the University of Oxford, and has worked in research communications for over 15 years. In her currently role as Communications Manager for IDDO, she provides strategic communications advice and implements IDDO's communications strategy across various communications channels, including the IDDO website and social media. She also line manages the IDDO communications officer.
IDDO’s team looks forward to sharing its latest research at ASTMH
09 Oct 2023
Join IDDO and WWARN’s researchers at this year’s ASTMH - the 72nd annual meeting in Chicago, USA, where we will be presenting on Visceral Leishmaniasis, malaria, and medicine quality across symposia, oral presentations and posters.
This year IDDO will be at stand #305, as part of Oxford Tropical Medicine, University of Oxford. Come and see us to find out about more about our research, data platforms and latest work.
Symposia - October 20
IDDO’s team is hosting a symposium titled: ‘From a single dataset to a million patients: Solutions to pool and harmonise IPD for effective and equitable reuse of data to generate new evidence in an open science framework’. Taking place on Friday, 20 Oct 4.00pm to 5.45pm (CST) the symposium will be chaired by Professor Philippe Guerin and Dr Manju Rahi, with presentations by:
Kalynn Kennon: Solutions to open science and data reuse;
- Dr Rob Terry: Governance of data reuse
- Dr Rob Commons: The impact of data reuse in malaria
- Maria Jesus Pinazo: The impact of data reuse in NTDs
- Professor Phaik Yeong Cheah: Applications and next steps in new environments
Symposia - October 22
IDDO’s Medicine Quality Research Group will host a symposium titled 'Countering the Wicked Problem of Bad Quality Medicines'. It has been organised by Professor Marya Lieberman, of U. Notre Dame, USA, and Professor Paul Newton and takes place on Sunday, October 22, at 8am (CST)
The presentation topics are systems/supply chains, pharmaceuticals and medical products and include:
Systems/Supply chains:
- Ashley Lee presenting on behalf of Professor Sachiko Ozawa, of the University of North Carolina Eshelman School of Pharmacy (UNC): Modelling the economic and clinical impact of substandard and falsified drugs
- Dr Céline Caillet, University of Oxford-MORU Tropical Health Network/Infectious Diseases Data Observatory: An app (Epione) for facilitating medicine quality surveys
Pharmaceuticals:
- Dr Noudy Sengxeu (University of Health Sciences, Vientiane, Lao PDR): ABACUS2-MQ Survey of the quality of antibiotics in four countries
- Dr Ayenew Ashenef (pre-recorded talk), Addis Ababa University--Department of Pharmaceutical Chemistry and Pharmacognosy: Quality of chemotherapy drugs in Ethiopia
Medical products:
- Dr Céline Caillet, presenting on behalf of Professor Paul Newton, University of Oxford-MORU Tropical Health Network/Infectious Diseases Data Observatory: Evaluation of devices for detecting substandard and falsified vaccines in supply chains
This symposium will also include a Poster Session and ‘petting zoo’ for medicine screening devices.
There will be an informal meeting of those interested in medicine quality research, policy and implementation from 11am to 2.30pm, on Saturday, October 21, in the San Francisco Room - Ballroom Level (West Tower), Hyatt Regency Chicago. Please let Paul Newton know if you would like to attend.
Dr Robert Commons, of Menzies School of Health Research, Darwin, Australia, and WWARN Postdoctoral Researcher (ARC-A), will chair a symposium titled: ‘Emerging data on how best to use primaquine and tafenoquine for the radical cure of P. vivax’ on Sunday, October 22, from 8am to 9.45am (CDT).
The speakers include:
- Megha Rajasekhar, The University of Melbourne: Trade-off between short term hemolytic risk and long-term benefit of 8-aminoquinoline treatment
- Dr Ihsan Fadilah, Oxford University Clinical Research Unit Indonesia: Is there a way to individualize P. vivax radical cure regimens? Methemoglobin as a marker of antirelapse efficacy
- Brice Campo, Medicines for Malaria Venture: How in vitro and in vivo vivax malaria models can help us understand the outcome of past clinical studies with tafenoquine and design the next set of studies
- Marcus Vinícius Guimarães de Lacerda, Doctor Heitor Vieira Dourado Tropical Medicine Foundation, Brazil: The Tafenoquine Roll-out STudy (TRuST): Real-world evidence on feasibility of providing appropriate P. vivax radical cure with tafenoquine or primaquine after G6PD testing in the Brazilian Amazon – final results from a study of over 6000 patients
Visitors can join Professor Joel Tarning’s oral presentation: Pharmacometric assessment and dose-optimisation of primaquine in the radical cure of Plasmodium vivax malaria in children: an individual patient data meta-analysis on Thursday, October 19, from 3pm to 4.45pm at Scientific Session 34: Malaria: Drug Development and Clinical Trials.
IDDO and WWARN’s researchers are also presenting a number of posters at ASTMH, these are:
Poster Session A: Thursday, October 19, Noon – 1:45 pm United States Central Time Zone
- Dr Rob Commons: Safety and efficacy of primaquine in patients with P. vivax malaria from South Asia: A systematic review and individual patient data meta-analysis #5386
Poster Session B, Friday, October 20, Noon – 1:45 pm United States Central Time Zone
- Dr Prabin Dahal: Host, parasite and drug determinants of treatment outcomes in Visceral Leishmaniasis: An individual patient data meta-analysis using the Infectious Diseases Data Observatory data platform #6351
- Dr Sauman Singh: Ophthalmological Complications in Visceral Leishmaniasis and Post Kala-Azar Dermal Leishmaniasis #6350
Poster Session C, Saturday, October 21, 11 am – 12:45 pm United States Central Time Zone
- Dr Prabin Dahal: Haemoglobin dynamics following treatment of Visceral Leishmaniasis: An individual patient data meta-analysis using the Infectious Diseases Data Observatory data platform #7064
- Professor Joel Tarning, Head of WWARN Pharmacometric Modelling and Co-Head IDDO Asia Pacific Centre - Thailand (ARC - T) - Artemether-lumefantrine as a chemoprophylactic treatment of malaria #6918
- Dr Martin Walker: The lymphatic filariasis treatment study landscape: a systematic review of study characteristics and the case for an individual participant data platform #7039
ASTMH takes place from October 18 to 22, Hyatt Regency Chicago, and more than 4,000 researchers, scientists, physicians and global health experts are expected to attend. For more information view https://www.astmh.org/
If you are not able to join us in-person then why not follow what is happening at the conference over Twitter by following us on @IDDOnews
Read our latest news or email info@iddo.org with your questions.
CDISC compliant case report forms for uncomplicated VL and VL-HIV co-infection: A unique collaborative effort by VL experts and a first in NTDs
22 Jun 2023
A global collaboration of the visceral leishmaniasis (VL) community has developed freely available, annotated case report forms (CRF) to accelerate research both into uncomplicated VL and specifically for patients with HIV-VL co-infection. The CRFs allow the collection of research-related data in a standard format, enabling the research community to capture data that is accessible, interoperable and re-useable for future analysis and collaboration. This harmonised approach to data collection will maximise the value of data for more efficient and meaningful research that has an invaluable impact on global health.
In 2020, scientists and researchers from the VL research community, pharmaceutical industry, drug regulators, policy makers, and key national and global health partners developed the first poverty-related infectious disease CRF to have been annotated using Clinical Data Interchange Standards Consortium (CDISC) standards. During its development, it became clear that with the falling number of leishmaniasis cases, the proportion of patients with HIV co-infection were increasingly important to the control and elimination of the disease. However, these patients do not fit the standard criteria normally required within a clinical trial making conducting studies extremely challenging. Capitalising on the earlier uncomplicated VL CRF work, a specific CRF for HIV-VL co-infection has now been developed with user guides available for both.
Previously, there was no recognised standard approach to guide methods of recording, storing and reporting the VL clinical trial data required for research, and subsequent drug development. This made comparing studies and data relating to the efficacy of treatments from different groups of researchers challenging. However, the new CRFs provide researchers with a standardised means of recording any data they choose to collect according to a study protocol, allowing study endpoints to be comparable and permitting data from disparate sources to be harmonised and pooled for secondary use. The CRFs also utilise CDISC-compliant terminology. CDISC standards are required by the United States Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA); recommended by the China National Medical Products Administration (NMPA); and adopted by the world’s leading research organisations.
Institutions involved in the collaborations, spearheaded by the Infectious Diseases Data Observatory (IDDO) and the Drugs for Neglected Diseases Initiative (DNDi), with support from CDISC, included the International Centre for Diarrhoeal Disease Research (icddr,b,) Bangladesh; University of Brasilia, Brazil; University of Gondar, Ethiopia; Kala-Azar Medical Research Centre (KAMRC), Rajendra Memorial Research Institute of Medical Sciences (RMRI), the Indian Council for Medical Research (ICMR), Institute of Postgraduate Medical Education & Research (IPGMER) and PATH, India; Médecins Sans Frontières (MSF); University of Khartoum, Sudan; as well as researchers from GlaxoSmithKline (GSK) and Novartis; representatives of the regulatory medicines agencies from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA); and national and global health organisations including the Bill & Melinda Gates Foundation and the World Health Organization (WHO).
The case report form for uncomplicated VL CRF was used for the first time in a clinical trial conducted by DNDi in 2021.
Find out more and download the CRFs
About Visceral Leishmaniasis
VL, also known as kala-azar, is transmitted to humans through bites from infected female phlebotomine sand flies. If left untreated, it is fatal in 95% of cases. Globally, it is estimated that there are up to 22,000 new cases of VL each year which occur in Brazil, Ethiopia, India, Kenya, Somalia, South Sudan and Sudan.
About the global collaboration
The group initially met in New Delhi, India, in February 2020, at a meeting co-organised by IDDO and DNDi, to form a collaboration to create this freely available VL case report form. Expert working groups on VL core outcomes, biomarkers and HIV-VL co-infection were convened to refine the case report form, before a two-part, high-level roundtable achieved consensus across all stakeholders. Remote roundtable meetings with specialists in VL-HIV coinfection were convened in 2021-2022 to address specific data collection for VL-HIV coinfected populations.
Find out more about the process behind the development of the VL CRF.
Shanti
Rochester
Project Officer – Data Sharing
Research Theme
Malaria
Visceral leishmaniasis
Schistosomiasis & STHs
Chagas
Ebola
COVID19
WWARN
Shanti Rochester joined IDDO in June 2023. As a Project Officer – Data Sharing, she supports global governance processes and policies that encourage data to be shared and reused responsibly.
Prior to joining IDDO, Shanti carried out field research on maternal and infant health in Uganda and quantitative analyses on community-resilience initiatives (CRIs) affecting rural communities throughout the COVID-19 pandemic. Likewise, she has experience in fundraising within the contexts of Brazil and East Africa.
Shanti holds a BSc in Political Science with a Specialisation in International Relations and Organisations from Leiden University in the Netherlands and a MSc in Development Studies from SOAS University of London.
Case report form for VL HIV coinfection - user guide
IDDO at CUGH: connecting with the global health community
27 Apr 2023
Matt Brack, IDDO’s Senior Programme Manager, recently presented on our equitable approach to data collaborations in global health research at the Consortium of Universities for Global Health Conference (CUGH) in Washington, DC.
It was a busy few days as around 1,500 participants represented 65 countries at the event, which was highly multi-disciplinary, addressing topics ranging from implementation research and policy influence to funding strategy and operational capacity in resource-limited settings, all aligned with CUGH’s aim to support the university as a transforming force in global health.
Matt was joined by IDDO Data Access Committee (DAC) member, Dr Joan H. Shepherd, from the Sierra Leone Ethics and Scientific Review Committee (Ministry of Health and Sanitation) and Principal of the National School of Midwifery who was at the conference to present her work in a session on equity and innovation in health professional education: Covid-19 Pandemic and Post-Pandemic. Dr Shepherd also co-presented a poster on the IDDO DAC as a governance model for data reuse platforms.
“Participating at the recent CUGH Conference offered a unique opportunity to engage in face-to-face interaction with other professionals in the global health drive,” said Dr Shepherd. “Discussions around the presentations by speakers were lively and engaging, paving the way for future areas of collaboration and interest.
“IDDO’s contributions to the conference strategically highlighted ongoing work in selected infectious diseases as it positions sound structures, reliable processes and project outputs of its various research areas contributing to the overall story.”
Several IDDO partner institutions had a prominent role in the conference, including ICDDR,B (International Centre for Diarrhoeal Disease Research, Bangladesh), Nigeria Centre for Disease Control and TDR, the Special Programme for Research and Training in Tropical Diseases, hosted at WHO, who oversee IDDO’s data governance.
Dr Shepherd continued: “Certainly, global health discussions cannot be without mention of infectious diseases, especially since the Ebola outbreak in Guinea, Sierra Leone and Liberia. The work of IDDO makes room for reflection on the critical role of research and use of data to inform policy and practice in low-resourced countries.
“Participants showed a keen interest in the work of IDDO. The poster presentation and speaker’s platform provided an opportunity to share IDDO’s success stories and influence on clinical research. Matt’s presence provided finer details on the relevance of the data repository and enhanced the knowledge base of participants, drawing attention to the important work of data reuse through the data repository.
“The wealth of unused data is the “missing piece of the puzzle” in global health, and its potential value and scientific contribution is well accounted for throughout IDDO’s narrative on utilising data to inform policy and global health action justifiably through its data repository and equitable access.
“Personally, the conference stimulated a deeper sense of responsibility to contribute to collaborative research as a priority area now and in the future. Encounters at the CUGH conference further energised and inspired one to do more through global networks and collaborative partnerships. It enhances the thirst for continuous professional development and education, particularly during pandemics, and getting to know what others are doing in contributing towards achieving the vision of global health.”
About CUGH
Initially formed in 2009 by a handful of U.S. universities, the 14th Annual Consortium of Universities for Global Health Conference has expanded to include a growing membership of institutions in the Global South, and IDDO presented its work in the context of a session on Decolonization: Reforming Global Health, Equity, Justice, Education and Research.
CUGH represents a powerful global network to help deliver shared solutions to problems for universities in the global health space that would otherwise be tackled in isolation, with representative committees and expert working groups covering advocacy, education, operations, research, ethics and legal matters. IDDO will be maintaining links established at the conference in order both to learn, and to share its experience in equitable approach to data collaborations in global health research.