Malaria Infections and Infestations Malaria
Conditions
Interventions
Lapdap™ versus Coartem®.
Sponsors
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 6 and 59 months (although the lower age limit for Lapdap™ use is three months according to the label, malaria is rare among those below six months of age) 2. Weight of 5 - 16 kg 3. Presence of fever (axillary temperature greater than or equal to 37.5°C) and/or history of fever within two days 4. Uncomplicated malaria, slide-confirmed mono-infection of P. falciparum with 1000 - 100,000 rings/µl 5. The ability to attend follow-up visits 6. Informed consent provided by parent or guardian
Exclusion criteria
Exclusion criteria: 1. Malnutrition, defined as a child whose weight-for-height is below -3 SDs or less than 70% of the median of the National Center for Health Statistics (NCHS)/World Health Organization (WHO) normalised reference values 2. Known history of G6PD defficiency, methaaemogloin reductase deficiency, Haemoglobin M or E, or porphyria 3. Evidence of severe malaria as defined in WHO 2000 4. Hb equal to or less than 7 g/dl 5. Hypersensitivity to biguanides (e.g. proguanil, chlorproguanil) or sulphonamides such as fancidar and septrin 6. Evidence of concomitant fibrile infection 7. Treatment with antimalarial drugs within the past 14 days or 7 days with quinine (full course), proguanil, artemisinins, tetracycline doxycycline or clindamycin. Patient shall not be excluded on the basis of reported prior treatment with other anti-malarial drugs within the past 24 hours if they have a temperature and parasitemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effectiveness of Lapdap™ and Coartem® through clinical and parasitological responses. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To document the frequency and type of potential drug related adverse events 2. To assess community compliance and acceptability of Lapdap™ and Coartem® use 3. To determine the prevalence and to monitor the development of dhfr/dhps gene mutations which are markers of resistance | — |
Countries
Tanzania
Outcome results
None listed