Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated P.Falciparum Malaria in Children

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jomaa Pharma GmbH
• Collaborators: Fundacio Clinic; Fundacio Clinic Barcelona; Hospital Clinic of Barcelona
• Treatments: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Fosfomycin; Fosmidomycin

Criteria

Inclusion Criteria:

• Male subjects aged six months to three years

• Female subjects aged six months to three years

• Body weight >5kg

• Acute (symptoms lasting less than 14 days) uncomplicated P falciparum malaria

• Asexual parasitaemia between 1,000/µL and 200,000/µL

• Ability to tolerate oral therapy

• Willingness of the parent or guardian to provide informed signed consent

Exclusion Criteria:

• Symptoms/signs of severe malaria, according to WHO criteria

• Body weight <5kg

• Other plasmodial infections (P vivax, P ovale, P malariae)

• Severe malnutrition with weight for age <60% or clinical kwashiorkor

• Gastro-intestinal disturbance with persistent vomiting (> three episodes within previous 24 hours) and/or diarrhoea (> 5 loose stools in the preceding 24 hours)

• Concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment

• Haemoglobin <7g/dl

• Adequate anti-malarial treatment within previous 7 days

• Inability to tolerate oral therapy

• Parent or guardian deemed to be unsupportive

• On co-trimoxazole prophylaxis