Evidence map›Paper›PMID 26526926›Full record

Trial reportThe American journal of tropical medicine and hygiene2016

Short-Course Treatment Regimen of Indian Visceral Leishmaniasis with an Indian Liposomal Amphotericin B Preparation (Fungisome™).

Rama P Goswami, Rudra P Goswami, Sukhen Das, Aditya Satpati, Mehebubar Rahman

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Comparative efficacy, toxicity and biodistribution of the liposomal amphotericin B formulations FungisomeInternational journal for parasitology. Drugs and drug resistance · 2018
    Article
  6. Observational
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Rama P GoswamiDepartment of Tropical Medicine, Calcutta School of Tropical Medicine, West Bengal, India; Department of Rheumatology, Institution of Post Graduate Medical Education and Research, West Bengal, India; Department of Medicine, ESI Hospital, Joka, West Bengal, India.
Rudra P GoswamiDepartment of Tropical Medicine, Calcutta School of Tropical Medicine, West Bengal, India; Department of Rheumatology, Institution of Post Graduate Medical Education and Research, West Bengal, India; Department of Medicine, ESI Hospital, Joka, West Bengal, India rudra.goswami@gmail.com.
Sukhen DasDepartment of Tropical Medicine, Calcutta School of Tropical Medicine, West Bengal, India; Department of Rheumatology, Institution of Post Graduate Medical Education and Research, West Bengal, India; Department of Medicine, ESI Hospital, Joka, West Bengal, India.
Aditya SatpatiDepartment of Tropical Medicine, Calcutta School of Tropical Medicine, West Bengal, India; Department of Rheumatology, Institution of Post Graduate Medical Education and Research, West Bengal, India; Department of Medicine, ESI Hospital, Joka, West Bengal, India.
Mehebubar RahmanDepartment of Tropical Medicine, Calcutta School of Tropical Medicine, West Bengal, India; Department of Rheumatology, Institution of Post Graduate Medical Education and Research, West Bengal, India; Department of Medicine, ESI Hospital, Joka, West Bengal, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

India bears the burden of about half of global visceral leishmaniasis (VL) cases with emerging problems of stibanate resistance. Liposomal preparations have improved treatment outcome through shorter duration of therapy and lower toxicity compared with conventional amphotericin B. We report the efficacy of two short-course regimens of an Indian preparation of liposomal amphotericin B (Fungisome™) for VL caused by Leishmania donovani in India. An open-label, randomized, single-center comparative study was undertaken from 2008 to 2011, involving 120 treatment naive non-human immunodeficiency virus VL patients randomly allocated to two groups. Fungisome™ was given, in groups A (N = 60), 5 mg/kg daily for 2 days and B (N = 60), 7.5 mg/kg daily for 2 days, as intravenous infusion. Initial cure rate was 100% in both the groups after 1 month posttreatment. At 6 months after completion of treatment, definitive cure rate was group A 90% (54/60, 95% confidence interval (CI): 80.55-95.72%); group B: 100% (95% CI: 95.92-100%); (P = 0.027). No serious adverse events occurred in either group. The short-course, 2-day regimen of 15 mg/kg Fungisome™ infusion is easy to administer, effective, and safe for treatment of VL caused by L. donovani in India.

Indexed as

AdolescentAdultAmphotericin BAntiprotozoal AgentsChildChild, PreschoolDrug Administration ScheduleFemaleHumansIndiaLeishmaniasis, VisceralMaleYoung AdultAmphotericin BAntiprotozoal Agentsliposomal amphotericin B

Identifiers

PMID26526926
PMCPMC4710453

What OpenQuestion holds

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Registered trials

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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.