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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00677833 |
Purpose
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 |
|---|---|---|
|
Malaria, Falciparum |
Drug: Azithromycin plus Chloroquine Drug: Chloroquine Drug: Artemether-lumefantrine |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 361 |
| Study Start Date: | June 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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)
|
| Experimental: 2 |
Drug: Artemether-lumefantrine
Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)
|
Eligibility| Ages Eligible for Study: | 6 Months to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Burkina Faso | |
| Pfizer Investigational Site | |
| Nouna, Burkina Faso | |
| Pfizer Investigational Site | |
| Ouagadougou, Burkina Faso | |
| Pfizer Investigational Site | |
| Ouagadougou 01, Burkina Faso | |
| Côte D'Ivoire | |
| Pfizer Investigational Site | |
| Abidjan 13, Côte D'Ivoire | |
| Ghana | |
| Pfizer Investigational Site | |
| Navrongo, Ghana | |
| Kenya | |
| Pfizer Investigational Site | |
| Kisumu, Kenya, 40100 | |
| Mali | |
| Pfizer Investigational Site | |
| Bamako, West Africa, Mali | |
| Pfizer Investigational Site | |
| Sikasso, West Africa, Mali | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc |
| ClinicalTrials.gov Identifier: | NCT00677833 History of Changes |
| Other Study ID Numbers: | A0661157 |
| Study First Received: | May 12, 2008 |
| Last Updated: | June 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
P. Falciparum Malaria drug treatment clinical trial |
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Artemether Artemisinins Lumefantrine Artemether-lumefantrine combination Azithromycin Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents |