Clinical Trial: Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated P.Falciparum Malaria in Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Children
Brief Summary:
This is an open label uncontrolled study to determine the efficacy of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children.
The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
Detailed Summary:
An open label uncontrolled study to determine the efficacy of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated Plasmodium falciparum malaria in children.
The primary study endpoints will be the cure rate on Day 28 (PCR corrected). The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
Study population A total of 40 children will be recruited into the study. Sample size calculations have been made on the basis that this trial aims at substantiating the efficacy results obtained in children in Gabon. In the largest trial of this drug combination done in Gabon, 51 children were recruited, and the per-protocol, PCR-adjusted day 28 cure rate was 89% (42/47; 95% CI, 77 to 96%). Based on this expected 90% efficacy estimate, a sample size of 35 children produces a two-sided 95% confidence interval with a an estimated precision of 20%.
Allowing for an attrition rate of 10% for non-evaluable subjects, a sample size of 40 subjects will be required.
Study endpoints Primary The primary endpoint will be the cure rate on Day 28 (PCR corrected). Secondary The secondary endpoints will be the cure rate on Day 7 and the parasite and fever clearance times.
Withdrawal criteria during treatment (classified as therapeutic failure)
- Severe deterioration in clinical condition
- Signs of severe malaria, according to WHO criteria
- Onset of drug related serious adverse events
- Repeated vomiting within one hour of re-do
Sponsor: Jomaa Pharma GmbH
Current Primary Outcome: Day 28 cure rate >95% [ Time Frame: 28 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Day 7 cure rate of 100% [ Time Frame: Day 6 ]
- Parasite Clearance Time [ Time Frame: 0-7 days ]
- Fever Clearance Time [ Time Frame: 0-7 days ]
Original Secondary Outcome: Same as current
Information By: Jomaa Pharma GmbH
Dates:
Date Received: October 26, 2009
Date Started: September 2010
Date Completion:
Last Updated: November 2, 2011
Last Verified: November 2011