Trial reportPloS one2017
To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL).
Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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
19 citing papers in PubMed, 36 citations in OpenAlex.
- 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
- Cyclodextrin-AmB-IL-10 antagonist peptide nanoparticles treat leishmaniasis more effectively than conventional AmB.Nanomedicine (London, England) · 2025Article
- Treatment Outcomes of Single-Dose Liposomal Amphotericin B-Treated Visceral Leishmaniasis Patients and Factors Affecting Outcome in Bihar, India.The American journal of tropical medicine and hygiene · 2024Article
- Amphotericin B Deoxycholate Treatment of Post-Kala-Azar Dermal Leishmaniasis in India.The American journal of tropical medicine and hygiene · 2024Article
- Skin pharmacokinetics of miltefosine in the treatment of post-kala-azar dermal leishmaniasis in South Asia.The Journal of antimicrobial chemotherapy · 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
- Amphotericin B resistance in Leishmania mexicana: Alterations to sterol metabolism and oxidative stress response.PLoS neglected tropical diseases · 2022Article
- Tolerability and epidemiology of nephrotoxicity associated with conventional amphotericin B therapy: a retrospective study in tertiary care centers in Palestine.BMC nephrology · 2022Article
- Post kala-azar dermal leishmaniasis: A threat to elimination program.PLoS neglected tropical diseases · 2020Review
- Conversion of asymptomatic infection to symptomatic visceral leishmaniasis: A study of possible immunological markers.PLoS neglected tropical diseases · 2020Article
- Report of the Fifth Post-Kala-Azar Dermal Leishmaniasis Consortium Meeting, Colombo, Sri Lanka, 14-16 May 2018.Parasites & vectors · 2020Article
- Policy Recommendations From Transmission Modeling for the Elimination of Visceral Leishmaniasis in the Indian Subcontinent.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Article
- Post-kala-azar dermal leishmaniasis in the Indian subcontinent: A threat to the South-East Asia Region Kala-azar Elimination Programme.PLoS neglected tropical diseases · 2017Review
- Therapeutic Modalities in Post Kala-azar Dermal Leishmaniasis: A Systematic Review of the Effectiveness and Safety of the Treatment Options.Indian journal of dermatologyArticle
- Combination Therapy for Post-Kala-Azar Dermal Leishmaniasis: A Literature Review of Current Evidence.Indian journal of dermatologyReview
- Barriers to the effective management and prevention of post kala-azar dermal leishmaniasis (PKDL) in the Indian subcontinent.Medical journal, Armed Forces IndiaReview
- Amphotericin-B in Dermatology.Indian dermatology online journalArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPost kala-azar dermal leishmaniasis (PKDL) is a skin disorder that usually occurs among patients with a past history of visceral leishmaniasis (VL). Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized trial in 50 PKDL patients.
methodsIn this open label study 50 patients with PKDL, aged between 5-60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5% dextrose, daily for 20 infusions for 3 courses at an interval of 15 days between each course and Group B received amphotericin B in the dose of 1mg/kg in 5% dextrose on alternate days, 20 infusions for 3 courses an interval of 15 days between each course and followed up for one year.
resultsA total of 50 patients were enrolled, 25 in each of group A and group B. Two patients lost to follow up and three patients withdrew consent due to adverse events. The initial cure rate was 92% in group A and 88% in group B by intention to treat analysis and final cure rate by per protocol analysis was 95.65% and 95.45% in group A and group B respectively. Two patients each from either group relapsed. Nephrotoxicity was the most common adverse event occurring in both the groups.
conclusionThe lower dose appears to have fewer adverse events however, nephrotoxicity remains a problem in both regimens. The 0.5mg/kg regimen may be considered instead of the higher dosage however safer treatments remain critical for PKDL treatment.
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Registered trials
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.