Assessing delivery mechanism for the use of rectal artesunate in management of non per os malaria
| ISRCTN | ISRCTN58046240 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58046240 |
| Secondary identifying numbers | A20679 - Tanzania; A20634 - Guinea-Bissau; A20130 - Uganda; A20133 - Ghana; A30173 - Zambia |
- Submission date
- 05/04/2005
- Registration date
- 07/06/2005
- Last edited
- 07/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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
| gomesm@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Assessing delivery mechanism for the use of rectal artesunate in management of non per os malaria |
| Study objectives | That a delivery system that uses caretakers (MOTHERS) to deliver rectal artesunate will significantly increase coverage of the drug compared with alternative deliery systems. |
| Ethics approval(s) | Approval received from: 1. National Ethics Committees in the participating countries 2. World Health Organization (WHO) Ethics Review Committee |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Primary endpoint of coverage (% children requiring drug that got the drug) does not depend upon number of participants, therefore no exact number of participants. Community is the level of randomisation. The three arms are: 1. Treatment using existing health care workers/volunteers/providers 2. Research informed community based system 3. Caretaker-mother based delivery system Countries can choose to do a two arm study or a three arm study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Artesunate |
| Primary outcome measure | The coverage of non per os patients achieved. |
| Secondary outcome measures | 1. The time taken to deliver the drug to the patient 2. The proportion of non per os patients who followed referral advice 3. The proportion of non per os patients who took consolidation treatment 4. The proportion of non per os patients who needed the drug but were excluded from treatment, and the proportion of per os patients who were given treatment and should have been excluded from treatment 5. The convenience and acceptability of treatment via the provider 6. The training requirements for the drug dispensers 7. The handling and utilisation of rectal artesunate suppositories, adherence to correct treatment procedures, adherence to training in recognition, referral to hospital/provision of consolidation treatment 8. Recording of treatment outcome 9. Recording severe adverse reactions 10. Documentation: number of suppositories used, number of suppositories in the village stock |
| Overall study start date | 27/06/2003 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | N/A - see interventions section below |
| Key inclusion criteria | 1. Children and adults of any age group 2. Clinical diagnosis of probable P. falciparum malaria 3. Consent by patient or parent guardian 4. Presence of one or more of the following conditions: 4.1. Repeated vomiting 4.2. Inability to eat, drink, or suck 4.3. Recurrent convulsions 4.4. Obtuned response to painful stimuli 4.5. Coma |
| Key exclusion criteria | 1. Children below three months age 2. Patients who are per os or can take drugs by mouth 3. Non-residents of the study area, unlikely to stay at least a week after treatment |
| Date of first enrolment | 27/06/2003 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Ghana
- Guinea-Bissau
- Switzerland
- Tanzania
- Uganda
- Zambia
Study participating centre
World Health Organization
Geneva -27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation
Research organisation
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/12/2016 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: Publication reference added.
