Status:
COMPLETED
Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated P.Falciparum Malaria in Children
Lead Sponsor:
Jomaa Pharma GmbH
Collaborating Sponsors:
Fundacio Clinic Barcelona
Hospital Clinic of Barcelona
Conditions:
Malaria
Eligibility:
All Genders
6-3 years
Phase:
PHASE2
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 falcip...
Detailed Description
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 mal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01464138
Start Date
September 1 2010
End Date
September 1 2011
Last Update
November 3 2011
Active Locations (1)
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1
Centro de Investigacao em Saude da Manhica
Maputo, Mozambique