Condition category
Infections and Infestations
Date applied
05/04/2005
Date assigned
07/06/2005
Last edited
11/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Melba Gomes

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva -27
CH 1211
Switzerland
gomesm@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A20679 - Tanzania; A20634 - Guinea-Bissau; A20130 - Uganda; A20133 - Ghana; A30173 - Zambia

Study information

Scientific title

Acronym

Study hypothesis

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

Approval received from:
1. National Ethics Committees in the participating countries
2. World Health Organization (WHO) Ethics Review Committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Artesunate

Primary outcome measures

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 trial start date

27/06/2003

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

N/A - see interventions section below

Participant 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

Recruitment start date

27/06/2003

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Ghana, Guinea-Bissau, Tanzania, Uganda, Zambia

Trial participating centre

World Health Organization
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes