Evaluate impact of rectal artesunate on resolution of severe malaria and mortality (Bangladesh)

Completed

• Conditions: Malaria; Infections and Infestations

• Registration Number: ISRCTN83979018
• 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

Study Timeline

• Study Start: 2006-02-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Children above crawling age and adults of any age group
2. Clinical diagnosis of probable P. falciparum malaria (fever, or history of fever without any other obvious cause of fever). Clinical features must include fever or history of fever and at least one of the following:
2.1. Unable to take food, drink or suck
2.2. Prostration: inability to sit, stand or walk unaided
2.3. Any abnormal level of consciousness i.e. from abnormal behavior, obtunded (limited response to painful stimulus), to coma (unconsciousness with absent verbal response and non-specific or absent motor response)
2.4. Fits or history of fits (defined as more than one fit in the previous 24 hours)
3. Consent by patient or parent/guardian if patient is less than 18
4. Community informed consent - at the start of the study in that area, community consent to the project would have been obtained

Exclusion Criteria

1. Afebrile (history/examination)
2. Unwillingness to sign (or parental signature) informed consent for study participation
3. Ability to take oral medication
4. Diarrhoea (at least two loose bowel movements in the previous two hours)
N.B. Pregnant or breast-feeding women will not be excluded from the study. Status of pregnancy in female will be noted in the Case Record Form (CRF).

Study & Design

• Study Type: Interventional
• Study Design: Not specified