Trial reportThe American journal of tropical medicine and hygiene2015
Inadequacy of 12-Week Miltefosine Treatment for Indian Post-Kala-Azar Dermal Leishmaniasis.
Trial report in The American journal of tropical medicine and hygiene, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.
- The safety and efficacy of miltefosine in the long-term treatment of post-kala-azar dermal leishmaniasis in South Asia - A review and meta-analysis.PLoS neglected tropical diseases · 2019Pooled it
- A phase II, non-comparative randomised trial of two treatments involving liposomal amphotericin B and miltefosine for post-kala-azar dermal leishmaniasis in India and Bangladesh.PLoS neglected tropical diseases · 2024Trial
- IgG3 and IL10 are effective biomarkers for monitoring therapeutic effectiveness in Post Kala-Azar Dermal Leishmaniasis.PLoS neglected tropical diseases · 2021Trial
- Trial
- A randomized, open-label study to evaluate the efficacy and safety of liposomal amphotericin B (AmBisome) versus miltefosine in patients with post-kala-azar dermal leishmaniasis.Indian journal of dermatology, venereology and leprologyTrial
- Post-kala-azar dermal leishmaniasis: insights into underlying pathogenic mechanisms and genetic landscape.Frontiers in microbiology · 2026Review
- Leishmaniasis.Nature reviews. Disease primers · 2025Review
- Amphotericin B Deoxycholate Treatment of Post-Kala-Azar Dermal Leishmaniasis in India.The American journal of tropical medicine and hygiene · 2024Article
- Monitoring the Long-Term Effectiveness of Miltefosine in Indian Post-Kala-Azar Dermal Leishmaniasis.The American journal of tropical medicine and hygiene · 2024Article
- Post-kala-azar dermal leishmaniasis (PKDL) drug efficacy study landscape: A systematic scoping review of clinical trials and observational studies to assess the feasibility of establishing an individual participant-level data (IPD) platform.PLoS neglected tropical diseases · 2024Article
- Article
- Safety and Effectiveness of Miltefosine in Post-Kala-Azar Dermal Leishmaniasis: An Observational Study.Open forum infectious diseases · 2023Article
- A difficult to treatIDCases · 2023Article
- Quantitative monitoring of experimental and human leishmaniasis employing amastigote-specific genes.Parasitology · 2022Article
- Mathematical modelling of the use of insecticide-treated nets for elimination of visceral leishmaniasis in Bihar, India.Royal Society open science · 2021Article
- Post kala-azar dermal leishmaniasis: A threat to elimination program.PLoS neglected tropical diseases · 2020Review
- Report of the Fifth Post-Kala-Azar Dermal Leishmaniasis Consortium Meeting, Colombo, Sri Lanka, 14-16 May 2018.Parasites & vectors · 2020Article
- Iron trafficking in patients with Indian Post kala-azar dermal leishmaniasis.PLoS neglected tropical diseases · 2020Article
- Acute uveitis: A rare adverse effect of miltefosine in the treatment of post-kala-azar dermal leishmaniasis.Revista da Sociedade Brasileira de Medicina Tropical · 2020Article
- Clinical Proteomics Profiling for Biomarker Identification Among Patients Suffering With Indian Post Kala Azar Dermal Leishmaniasis.Frontiers in cellular and infection microbiology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Post-kala-azar dermal leishmaniasis (PKDL) is a chronic dermatosis that generally occurs after apparent cure of visceral leishmaniasis caused by Leishmania donovani. In view of the prolonged treatment regimens necessary for PKDL, noncompliance is a major limitation; an optimal regimen is yet to be defined, but 12 weeks of therapy with miltefosine is generally recommended. We performed a single-arm open-label trial of miltefosine administered daily for 16 weeks in 27 patients in Kolkata with PKDL. After 4 weeks of treatment, nine patients were lost to follow-up because of unacceptable side effects, including severe abdominal pain, nausea, and vomiting. Of the 18 remaining patients, seven completed 12 weeks of therapy and 11 completed 16 weeks of therapy. Three of the seven who received 12 weeks of therapy and none of the 11 who received 16 weeks of therapy experienced disease relapse. Our results suggest that a 16-week course of miltefosine is required for reliable cure of PKDL. Further, the study highlighted the urgent need for a multicentric randomized controlled trial of 12 versus 16 weeks of treatment with miltefosine for PKDL so as to achieve the goal of elimination of leishmaniasis in south Asia.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.