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
Protocol serial number	A20679 - Tanzania; A20634 - Guinea-Bissau; A20130 - Uganda; A20133 - Ghana; A30173 - Zambia
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: 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

World Health Organization
20 Avenue Appia
Geneva -27
CH 1211
Switzerland

Email	gomesm@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Artesunate
Primary outcome measure(s)	The coverage of non per os patients achieved.
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.