Effectiveness and pharmacovigilance of Lapdap™ and Coartem® for the treatment of uncomplicated falciparum malaria in northeastern Tanzania
| ISRCTN | ISRCTN08525528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08525528 |
| Protocol serial number | A40744 |
| Sponsor | UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) |
| Funders | Gates Foundation (USA), Glaxo SmithKline (GSK) (USA) - donating the Lapdap™ free of charge |
- Submission date
- 31/03/2006
- Registration date
- 31/03/2006
- Last edited
- 10/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ahmed Bellah
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Lapdap™ is likely to be as effective as Coartem® in malaria management when used in an unsupervised situation. |
| Ethics approval(s) | Ethics approval received on the 10th July 2005. |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Lapdap™ versus Coartem®. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lapdap™, Coartem® |
| Primary outcome measure(s) |
To assess the effectiveness of Lapdap™ and Coartem® through clinical and parasitological responses. |
| Key secondary outcome measure(s) |
1. To document the frequency and type of potential drug related adverse events |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | All |
| Target sample size at registration | 2600 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- Switzerland
- Tanzania
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
