Impact of early administration of artesunate suppository on childhood severe malaria in Tanzania
| ISRCTN | ISRCTN76987662 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76987662 |
| Protocol serial number | 980482 |
| Sponsor | UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) |
| Funders | United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR), European Commission (Belgium), WHO Global Malaria Programme, US Agency for International Development (USAID) (USA), Irish Aid (Ireland), Karolinska Institutet (Sweden), Sall Family Foundation (USA), University of Oxford Clinical Trial Service Unit (UK) |
- Submission date
- 01/02/2006
- Registration date
- 01/02/2006
- Last edited
- 23/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 3813 |
|---|---|
| gomesm@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The objective has been to establish whether, in patients with acute malaria who cannot take medication by mouth, rectal artesunate plus referral differs from rectal placebo plus referral in terms of death or permanent disability. |
| Ethics approval(s) | Ethics approval received on the 1st January 1999. |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | The sample size determination in the protocol specified that a total of 10,000 non per os patients would need to be randomised in order to detect a reduction of mortality from 5% to 3%. Individual patients will be randomised to receive either AS suppository (intervention group) or placebo (comparator group). Patients in both groups will then be referred immediately to the nearest hospital/health centre. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artesunate (AS) |
| Primary outcome measure(s) |
1. Number of relevant deaths in the intervention and control arm assessed 7 - 30 days after enrolment (relevant defined as malaria positive patients in whom the death was probably/definitely preventable by the intervention) |
| Key secondary outcome measure(s) |
1. Number of deaths in the intervention and control arm assessed 7 - 30 days following enrolment in the study |
| Completion date | 01/01/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 71 Months |
| Sex | |
| Key inclusion criteria | 1. Non per os children presenting to a peripheral health unit or traditional healer with clinicallly suspected P. falciparum malaria 2. Children (apparent age 6 months to 71 months) with suspected malaria who are too ill to take drugs by mouth 3. Individual informed consent - consent must have been given (generally by thumb-print) by the patient or guardian of the sick person 4. Community informed consent - at the start of the study in that area, community consent to the project would have been obtained |
| Key exclusion criteria | Ability to take an oral medication. |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 01/01/2001 |
Locations
Countries of recruitment
- Switzerland
- Tanzania
Study participating centre
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/02/2009 | Yes | No |
