Evidence map›Paper›PMID 21362162›Full record

Trial reportMalaria journal2011

Phase I randomized dose-ascending placebo-controlled trials of ferroquine--a candidate anti-malarial drug--in adults with asymptomatic Plasmodium falciparum infection.

Ghyslain Mombo-Ngoma, Christian Supan, Matthias P Dal-Bianco, Michel A Missinou, Pierre-Blaise Matsiegui, Carmen L Ospina Salazar, Saadou Issifou, Daniel Ter-Minassian, Michael Ramharter, Maryvonne Kombila and 2 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Malaria journal, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing 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

20 citing papers in PubMed.

  1. Trial
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  10. Malaria medicines: a glass half full?Nature reviews. Drug discovery · 2015
    Review
  11. Article
  12. Article
  13. Review
  14. Antiprotozoal activity of ferroquine.Parasitology research · 2013
    Article
  15. Review
  16. Review
  17. Article
  18. Review
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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

12 authors.

Ghyslain Mombo-NgomaMedical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon.
Christian Supan
Matthias P Dal-Bianco
Michel A Missinou
Pierre-Blaise Matsiegui
Carmen L Ospina Salazar
Saadou Issifou
Daniel Ter-Minassian
Michael Ramharter
Maryvonne Kombila
Peter G Kremsner
Bertrand Lell

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe development and spread of drug resistant Plasmodium falciparum strains is a major concern and novel anti-malarial drugs are, therefore, needed. Ferroquine is a ferrocenic derivative of chloroquine with proven anti-malarial activity against chloroquine-resistant and -sensitive P. falciparum laboratory strains.

methodsAdult young male aged 18 to 45 years, asymptomatic carriers of P. falciparum, were included in two-dose escalation, double-blind, randomized, placebo-controlled Phase I trials, a single dose study and a multiple dose study aiming to evaluate oral doses of ferroquine from 400 to 1,600 mg.

resultsOverall, 54/66 patients (40 and 26 treated in the single and multiple dose studies, respectively) experienced at least one adverse event, 15 were under placebo. Adverse events were mainly gastrointestinal symptoms such as abdominal pain (16), diarrhoea (5), nausea (13), and vomiting (9), but also headache (11), and dizziness (5). A few patients had slightly elevated liver parameters (10/66) including two patients under placebo. Moderate changes in QTc and morphological changes in T waves were observed in the course of the study. However, no adverse cardiac effects with clinical relevance were observed.

conclusionsThese phase I trials showed that clinically, ferroquine was generally well-tolerated up to 1,600 mg as single dose and up to 800 mg as repeated dose in asymptomatic young male with P. falciparum infection. Further clinical development of ferroquine, either alone or in combination with another anti-malarial, is highly warranted and currently underway.

Indexed as

Asymptomatic DiseasesAdolescentAdultAminoquinolinesAntimalarialsDouble-Blind MethodFerrous CompoundsHumansMalaria, FalciparumMaleMetallocenesMiddle AgedPlacebosPlasmodium falciparumTreatment OutcomeYoung AdultAminoquinolinesAntimalarialsferroquineFerrous CompoundsMetallocenesPlacebos

Identifiers

PMID21362162
PMCPMC3056844

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.