Assessing delivery mechanism for the use of rectal artesunate in management of non per os malaria
Completed
- Conditions
- MalariaInfections and Infestations
- Registration Number
- ISRCTN58046240
- Lead Sponsor
- ICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The coverage of non per os patients achieved.
- Secondary Outcome Measures
Name Time Method 1. The time taken to deliver the drug to the patient<br>2. The proportion of non per os patients who followed referral advice<br>3. The proportion of non per os patients who took consolidation treatment<br>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<br>5. The convenience and acceptability of treatment via the provider<br>6. The training requirements for the drug dispensers<br>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 <br>8. Recording of treatment outcome <br>9. Recording severe adverse reactions <br>10. Documentation: number of suppositories used, number of suppositories in the village stock