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To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin plus Chloroquine | Drug | Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2) |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa. | duration of trial | |
| The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population. | duration of trial |
| Measure | Description | Time Frame |
|---|---|---|
| A secondary objective is to assess the efficacy of azithromycin plus chloroquine. | duration of trial | |
| Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens. | duration of trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ouagadougou | West Africa | 01 | Burkina Faso | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25425434 | Derived | Sagara I, Oduro AR, Mulenga M, Dieng Y, Ogutu B, Tiono AB, Mugyenyi P, Sie A, Wasunna M, Kain KC, Djimde AA, Sarkar S, Chandra R, Robbins J, Dunne MW. Efficacy and safety of a combination of azithromycin and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomised clinical trials in African adults. Malar J. 2014 Nov 25;13:458. doi: 10.1186/1475-2875-13-458. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D002738 | Chloroquine |
| D015767 | Mefloquine |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| Mefloquine | Drug | Mefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0 |
|
| Nouna |
| Burkina Faso |
| Pfizer Investigational Site | Navrongo | West Africa | Ghana |
| Pfizer Investigational Site | Kisumu | Kisumu County | 40100 | Kenya |
| Pfizer Investigational Site | Bamako | West Africa | Mali |
| Pfizer Investigational Site | Bamako | Mali |
| Pfizer Investigational Site | Senegal | West Africa | Senegal |
| Pfizer Investigational Site | Ndola | Zambia |
| D000079426 |
| Vector Borne Diseases |
| Organic Chemicals |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |