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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00214643 |
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Date of registration:
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11/09/2005 |
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Primary sponsor: |
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Public title:
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Efficacy of Fosmidomycin-Clindamycin for Treating Malaria in Gabonese Children
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Scientific title:
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A Comparative Assessment of the Efficacy of Fosmidomycin-Clindamycin Versus Sulfadoxine-Pyrimethamine for the Treatment of Children With Uncomplicated Plasmodium Falciparum Malaria |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00214643 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Gabon
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Contacts
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Name:
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Saadou Issifou, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Albert Schweitzer Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Uncomplicated P. falciparum malaria
- P. falciparum asexual parasitaemia between 1,000/µL and 100,000/µL
- Body weight between 10 - 65 kg
- Ability to tolerate oral therapy
- Informed consent, oral assent of the child, if possible
- Residence in study area
Exclusion Criteria:
- Adequate anti-malarial treatment within the previous 7 days
- Antibiotic treatment for the current infection
- Previous participation in this clinical trial
- Haemoglobin < 7 g/dl
- Haematocrit < 23 %
- Leucocyte count > 15,000 /µL
- Mixed plasmodial infection
- Severe malaria (as defined by WHO)
- Any other severe underlying disease (cardiac, renal, hepatic diseases,
malnutrition, known HIV infection)
- Concomitant disease masking assessment of response
- History of allergy or intolerance against trial medication
Age minimum:
3 Years
Age maximum:
14 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Drug: clindamycin
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Drug: Fosmidomycin
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Primary Outcome(s)
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Clinical and parasitological cure rate by day 28
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Secondary Outcome(s)
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Fever clearance time
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Parasite clearance time
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Safety and tolerability of the two treatments during the entire study period
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Secondary ID(s)
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06/2005/FOS-CLIN/SP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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