Phase I randomized dose-ascending placebo-controlled trials of ferroquine - a candidate anti-malarial drug - in adults with asymptomatic Plasmodium falciparum infection
2011

Ferroquine: A New Anti-Malarial Drug

Sample size: 66 publication Evidence: moderate

Author Information

Author(s): Mombo-Ngoma Ghyslain, Supan Christian, Dal-Bianco Matthias P, Missinou Michel A, Matsiegui Pierre-Blaise, Ospina Salazar Carmen L, Issifou Saadou, Ter-Minassian Daniel, Ramharter Michael, Kombila Maryvonne, Kremsner Peter G, Lell Bertrand

Primary Institution: Medical Research Unit, Albert Schweitzer Hospital, Lambaréné, Gabon

Hypothesis

Can ferroquine be safely administered to adults with asymptomatic Plasmodium falciparum infection?

Conclusion

Ferroquine was generally well-tolerated up to 1,600 mg as a single dose and up to 800 mg as a repeated dose.

Supporting Evidence

  • 54 out of 66 patients experienced at least one adverse event.
  • Adverse events were mainly gastrointestinal symptoms.
  • No serious adverse events were reported during the trials.
  • Ferroquine showed a favorable safety profile in both single and multiple dose studies.
  • Participants were followed up for eight weeks after treatment.

Takeaway

Ferroquine is a new medicine that helps fight malaria and is mostly safe for people who don't feel sick.

Methodology

The study involved two Phase I trials with young male volunteers aged 18 to 45, assessing the safety and tolerability of ferroquine through single and multiple doses.

Limitations

The small number of participants limits the ability to draw significant conclusions about adverse events.

Participant Demographics

Asymptomatic male volunteers aged 18 to 45 years.

Digital Object Identifier (DOI)

10.1186/1475-2875-10-53

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