Skip to content

Assessing delivery mechanism for the use of rectal artesunate in management of non per os malaria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58046240
Enrollment
Unknown
Registered
2005-06-07
Start date
2003-06-27
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations Malaria

Interventions

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 randomisati

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The coverage of non per os patients achieved.

Secondary

MeasureTime frame
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

Countries

Ghana, Guinea-Bissau, Tanzania, Uganda, Zambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026