Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
Multicentre Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in African Children
1 other identifier
interventional
100
1 country
1
Brief Summary
Few efficient drugs for malaria treatment are available so far. Due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of Plasmodium falciparum, new drug combinations have to be actively investigated. The investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 26, 2011
May 1, 2011
3 months
May 24, 2011
May 25, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Cure rate
Cure rate at day 28 will be determined by PCR
Day 28
Secondary Outcomes (1)
cure rate
day 7
Study Arms (1)
Fosmidomycin and clindamycin treatment
EXPERIMENTALAll the subject will be given fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
Interventions
The study drugs will be co-administered under supervision by a study physician or nurse in doses of fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
Eligibility Criteria
You may qualify if:
- Male or female subjects aged three to ten years
- Body weight ≥12kg
- 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
You may not qualify if:
- Symptoms/signs of severe malaria, according to WHO criteria (see appendix I)
- Body weight \<12kg
- Other concomitant plasmodial infections (P vivax, P ovale, P malariae)
- Severe malnutrition with weight for height \<70% (according to WHO tables) 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
- Packed cell volume (PCV) on arrival \<22%
- Adequate anti-malarial treatment within previous 7 days
- Inability to tolerate oral therapy
- Parent or guardian deemed to be unsupportive
- On co-trimoxazole prophylaxis
- Any known allergies to the investigational products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zentopharm GmbHlead
- Albert Schweitzer Hospitalcollaborator
- Centro de Investigacao em Saude de Manhicacollaborator
Study Sites (1)
Medical Research Unit, Albert Schweitzer Hospital
Lambaréné, Gabon
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saadou Issifou, MD PhD
Medical Research Unit, Albert Schweitzer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 24, 2011
First Posted
May 26, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2011
Study Completion
December 1, 2011
Last Updated
May 26, 2011
Record last verified: 2011-05