Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| World Health Organization | OTHER |
| Avenue Appia 20 | UNKNOWN |
| CH - 1211 Geneva 27 | UNKNOWN |
| Switzerland |
This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Artemether-lumefantrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemether-lumefantrine | Drug | 20mg artemether and 120 mg lumefantrine, tablet, dose based on body weight, 3 days treatment 5 - < 10kg (BWG 1) = 6 doses of 1 tablet / 10 - < 15kg (BWG 2) = 6 doses of 1 tablet / 15 - ā¤ 25kg (BWG 3) = 6 doses of 2 tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients free of parasites at 7, 14 and at 28 days | ||
| Time to clearance from parasites (asexual forms) | ||
| Time to clearance of fever |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kemri-Wellcome Trust Programme | Kilifi | Kenya | ||||
| University College Hospital Malaria Research Laboratories Institute for Advance Medical Research and Training |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19038036 | Derived | Falade CO, Ogunkunle OO, Dada-Adegbola HO, Falade AG, de Palacios PI, Hunt P, Virtanen M, Oduola AM, Salako LA. Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children. Malar J. 2008 Nov 27;7:246. doi: 10.1186/1475-2875-7-246. |
Not provided
Not provided
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Time to clearance of gametocytes (parasite sexual forms) |
| Ibadan |
| Nigeria |
| Muhimbili University College of Health Sciences Department of Parasitology and Medical Entomology, Box 65011 | Dar es Salaam | Tanzania |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided