Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
Blood Parasite Load as an Early Marker to Predict Treatment Response in Visceral Leishmaniasis in Eastern Africa.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- Design, Conduct, Analysis, and Reporting of Therapeutic Efficacy Studies in Visceral Leishmaniasis: A Systematic Review of Published Reports, 2000-2021.The American journal of tropical medicine and hygiene · 2024Pooled it
- Safety and efficacy of paromomycin/miltefosine/liposomal amphotericin B combinations for the treatment of post-kala-azar dermal leishmaniasis in Sudan: A phase II, open label, randomized, parallel arm study.PLoS neglected tropical diseases · 2023Trial
- Analytical and clinical performance of in-house and commercial real-time PCR assays for diagnosingJournal of clinical microbiology · 2026Article
- Application of ddPCR for diagnosis and treatment monitoring of visceral leishmaniasis patients: addition of an ultrasensitive tool to the diagnostic arsenal.Microbiology spectrum · 2026Article
- Systemic inflammatory markers of visceral leishmaniasis treatment response in East Africa.PLoS neglected tropical diseases · 2026Article
- Prognostic models predicting clinical outcomes in patients diagnosed with visceral leishmaniasis: a systematic review.BMJ public health · 2026Article
- Pentraxin 3 Levels Reflect Inflammatory and Parasitic Activity in Human Visceral Leishmaniasis.Pathogens (Basel, Switzerland) · 2025Observational
- Diagnosis and Management of Visceral Leishmaniasis in Children: A French Retrospective Study.Open forum infectious diseases · 2025Article
- Advances and Challenges in the Diagnosis of Leishmaniasis.Molecular diagnosis & therapy · 2025Review
- A Quantitative Polymerase Chain Reaction (qPCR) Protocol Predictive of Treatment Outcome in Cutaneous Leishmaniasis Caused byOpen forum infectious diseases · 2025Article
- Insights to the HIV-associated visceral leishmaniasis clinical outcome: lessons learned about immune mediated disorders.Frontiers in immunology · 2025Review
- Cytokine profiles, blood parasite load and clinical features of visceral leishmaniasis in West Pokot County, Kenya.Parasitology · 2024Article
- Simplified molecular diagnosis of visceral leishmaniasis: Laboratory evaluation of miniature direct-on-blood PCR nucleic acid lateral flow immunoassay.PLoS neglected tropical diseases · 2024Article
- Visceral Leishmaniasis in a Twin Pregnancy: A Case Report and Review of the Literature.Journal of clinical medicine · 2024Review
- Leishmania blood parasite dynamics during and after treatment of visceral leishmaniasis in Eastern Africa: A pharmacokinetic-pharmacodynamic model.PLoS neglected tropical diseases · 2024Article
- Clinical performance of a quantitative pan-genusPractical laboratory medicine · 2023Article
- Review
- Molecular Detection of Neglected Tropical Diseases: The Case for Automated Near-Point-of-Care Diagnosis of Leishmaniasis.The American journal of tropical medicine and hygiene · 2023Article
- Blood parasite load by qPCR as therapeutic monitoring in visceral leishmaniasis patients in Brazil: a case series study.Revista da Sociedade Brasileira de Medicina Tropical · 2023Article
- Zika, Nipah and Kala-azar: Emerging lethal infectious diseases amid COVID-19 as an escalating public health threat in South India.Annals of medicine and surgery (2012) · 2022Article
Corrections and comments
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Authors and funding
16 authors at 7 institutions in 6 countries.
Funding
Abstract
backgroundTo expedite the development of new oral treatment regimens for visceral leishmaniasis (VL), there is a need for early markers to evaluate treatment response and predict long-term outcomes.
methodsData from 3 clinical trials were combined in this study, in which Eastern African VL patients received various antileishmanial therapies. Leishmania kinetoplast DNA was quantified in whole blood with real-time quantitative polymerase chain reaction (qPCR) before, during, and up to 6 months after treatment. The predictive performance of pharmacodynamic parameters for clinical relapse was evaluated using receiver-operating characteristic curves. Clinical trial simulations were performed to determine the power associated with the use of blood parasite load as a surrogate endpoint to predict clinical outcome at 6 months.
resultsThe absolute parasite density on day 56 after start of treatment was found to be a highly sensitive predictor of relapse within 6 months of follow-up at a cutoff of 20 parasites/mL (area under the curve 0.92, specificity 0.91, sensitivity 0.89). Blood parasite loads correlated well with tissue parasite loads (ρ = 0.80) and with microscopy gradings of bone marrow and spleen aspirate smears. Clinical trial simulations indicated a > 80% power to detect a difference in cure rate between treatment regimens if this difference was high (> 50%) and when minimally 30 patients were included per regimen.
conclusionsBlood Leishmania parasite load determined by qPCR is a promising early biomarker to predict relapse in VL patients. Once optimized, it might be useful in dose finding studies of new chemical entities.
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