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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00677833 |
The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.
Condition | Intervention | Phase |
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Malaria, Falciparum |
Drug: Azithromycin plus Chloroquine Drug: Chloroquine Drug: Artemether-lumefantrine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa |
Estimated Enrollment: | 424 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Azithromycin plus Chloroquine
Combination of Azithromycin plus Chloroquine Azithromycin (~30 mg/kg) + chloroquine (~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
Drug: Chloroquine
chloroquine (~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2)
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2: Experimental |
Drug: Artemether-lumefantrine
Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
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Ages Eligible for Study: | 6 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Burkina Faso | |
Pfizer Investigational Site | Active, not recruiting |
Nouna, Burkina Faso | |
Pfizer Investigational Site | Active, not recruiting |
Sapone, Burkina Faso | |
Pfizer Investigational Site | Active, not recruiting |
Ouagadougou 01, Burkina Faso | |
Ghana | |
Pfizer Investigational Site | Not yet recruiting |
Navrongo, Ghana | |
Kenya | |
Pfizer Investigational Site | Active, not recruiting |
Kisumu, Kenya, 40100 | |
Mali, West Africa | |
Pfizer Investigational Site | Recruiting |
Bamako, West Africa, Mali | |
Zambia | |
Pfizer Investigational Site | Not yet recruiting |
Ndola, Zambia |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A0661157 |
Study First Received: | May 12, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00677833 |
Health Authority: | United States: Food and Drug Administration |
P. Falciparum Malaria, drug treatment, clinical trial |
Benflumetol Protozoan Infections Clotrimazole Miconazole Chloroquine diphosphate Azithromycin |
Tioconazole Chloroquine Parasitic Diseases Malaria Artemether Malaria, Falciparum |
Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Physiological Effects of Drugs Antimalarials Anti-Bacterial Agents Antiparasitic Agents Sensory System Agents Therapeutic Uses Antifungal Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics Amebicides |
Coccidiostats Antinematodal Agents Coccidiosis Filaricides Antiplatyhelmintic Agents Anthelmintics Schistosomicides Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |