Evidence map›Paper›PMID 21396249›Full record

Trial reportAnnals of tropical medicine and parasitology2011

In a trial of the use of miltefosine to treat HIV-related cryptosporidiosis in Zambian adults, extreme metabolic disturbances contribute to high mortality.

E Sinkala, M Katubulushi, S Sianongo, A Obwaller, P Kelly

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Annals of tropical medicine and parasitology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 36% of its field
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

5 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Therapeutic effects of acetylspiramycin and garlicin on cryptosporidiosis among drug users.International journal for parasitology. Drugs and drug resistance · 2015
    Trial
  3. Review
  4. An update onJournal of parasitic diseases : official organ of the Indian Society for Parasitology · 2022
    Review
  5. 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 at 3 institutions in 3 countries.

E SinkalaTropical Gastroenterology and Nutrition Group, University of Zambia School of Medicine, Lusaka, Zambia.
M Katubulushi
S Sianongo
A Obwaller
P Kelly
Tropical Gastroenterology & Nutrition group · ZMUniversity of Zambia · ZMWilhelminen Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is still no effective treatment for cryptosporidiosis even though the disease has a significant impact on HIV-infected adults and children. Following evidence of the drug's promising efficacy in vitro, a phase-1-phase-2 study of miltefosine (given at 2.5 mg/kg for 14 days, with the dose capped at 100 mg/day) was recently initiated among Zambian adults with HIV-related cryptosporidiosis. Seven patients were recruited before the trial was terminated prematurely because of lack of efficacy and the development of severe adverse events. The latter may have been entirely drug-related or the result of extreme metabolic abnormalities already present in the patients enrolled in the trial. In future trials of miltefosine, attention will have to be paid to the possibility of metabolic abnormalities in the subjects investigated.

Indexed as

AdultAIDS-Related Opportunistic InfectionsCryptosporidiosisDiarrheaEarly Termination of Clinical TrialsFemaleFluid TherapyHumansLiverMalePhosphorylcholineRenal InsufficiencyTreatment OutcomeYoung AdultmiltefosinePhosphorylcholine

Identifiers

PMID21396249
PMCPMC4084659
OpenAlexW2086392109

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.