Efficacy and safety of rectal artesunate in paediatric patients - a randomised controlled study (Ghana and Tanzania)
| ISRCTN | ISRCTN78768405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78768405 |
| Protocol serial number | A20210 and A70334 |
| Sponsor | UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR) |
| Funder | 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) |
- Submission date
- 05/04/2005
- Registration date
- 07/06/2005
- Last edited
- 15/08/2008
- 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 Melba Gomes
Scientific
Scientific
World Health Organization
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 | Hypothesis that clinical response rates in children aged 3 to 24 months with non per os malaria treated with rectal artesunate will not be inferior to those who receive standard treatment of parenteral Quinine. Please note that as of 15/08/2008, this record was updated to include Tanzania in the countries of recruitment list. This country started recruitment on 08/05/2008 and was added in order to add to the patient numbers. Ethics approval for this site has also been added to this record, and the anticipated end date has also been updated. The previous anticipated end date for this trial was 30/09/2007. |
| Ethics approval(s) | Approved by: 1. The Committee on Human Research Publication and Ethics (CHRPE) of the School of Medical Sciences, Kwame Nkrumah University of Science and Technology, Kumasi on 20th January 2003 2. World Health Organization (WHO) Ethics Committee on 30th June 2003 and continuing review 15th November 2005 and 13 November 2007 3. The National Institute of Medical Research, Tanzania on 28th August 2007 |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Group A: Artesunate 10 mg/kg, rectal Group B: Quinine 20 mg dihydrochloride salt/kg, intra-muscular injection (followed by 10 mg/kg at 12 and 24 hours) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artesunate, quinine |
| Primary outcome measure(s) |
28-day disease-free survival, defined as patients who survived the 28-day period of follow-up with the peripheral blood free of the original genotype of malaria parasites. |
| Key secondary outcome measure(s) |
The parasitological outcomes and tolerability of a single dose of the rectal artesunate in children aged 3 to 24 months with non per os falciparum malaria. |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 24 Months |
| Sex | All |
| Target sample size at registration | 246 |
| Key inclusion criteria | 1. Aged 3 to 24 months 2. Suspected malaria with no other obvious cause of illness 3. P. falciparum asexual parasitaemia greater than ++ (5 - 10 parasites/High Power Field [HPF]) 4. Unable to eat, suck or drink, or repeatedly vomiting (more than three episodes over past 24 hours); or prostrate (unable to sit or stand if previously able to do so) 5. History of convulsions over the preceding 24 hours or impaired consciousness (Blantyre Coma Score less than five) 6. Parent/guardian informed consent |
| Key exclusion criteria | 1. Ability to tolerate oral intake 2. Acute diarrhoea defined as the presence of more than three episodes of watery stools in the preceding 24 hours 3. History of allergy to artemisinin compounds and/or quinine |
| Date of first enrolment | 30/06/2003 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- Ghana
- 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 |
