Evaluation of Fosmidomycin and Clindamycin in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria
NCT ID: NCT01361269
Last Updated: 2011-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2011-06-30
2011-12-31
Brief Summary
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Detailed Description
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The secondary objective is to differentiate between recrudescent parasitaemia and reinfection in the event of recurrent parasitaemia developing within the 28-day follow-up period, to determine the population pharmacokinetics of fosmidomycin when co-administered orally with clindamycin and to compare the in vitro sensitivity of isolates of Plasmodium falciparum to fosmidomycin.
The trial will include 100 children aged 3-10 years, divided between clinical sites of Gabon and Mozambique.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fosmidomycin and clindamycin treatment
All 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).
Fosmidomycin and clindamycin
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).
Interventions
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Fosmidomycin and clindamycin
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
3 Years
10 Years
ALL
No
Sponsors
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Albert Schweitzer Hospital
OTHER
Centro de Investigacao em Saude de Manhica
OTHER
Zentopharm GmbH
INDUSTRY
Responsible Party
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Medical Research Unit, Albert Schweitzer Hospital
Principal Investigators
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Saadou Issifou, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Medical Research Unit, Albert Schweitzer Hospital
Locations
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Medical Research Unit, Albert Schweitzer Hospital
Lambaréné, , Gabon
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FosClinChildren
Identifier Type: -
Identifier Source: org_study_id
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