Phase IV rectal artesunate clinical trial in the Kassena Nankana District of Ghana

ISRCTN	ISRCTN46343627
DOI	https://doi.org/10.1186/ISRCTN46343627
Protocol serial number	N/A
Sponsor	UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Funders	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), European Commission (Belgium), WHO Global Malaria Programme, US Agency for International Development (USAID) (USA), Irish Aid (Ireland), Karolinska Institutet (Sweden), Sall Family Foundation (USA), University of Oxford Clinical Trial Service Unit (UK)

Submission date: 01/02/2006
Registration date: 01/02/2006
Last edited: 23/02/2009

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

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone	+41 (0)22 791 3813
Email	gomesm@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The objective has been to establish whether, in patients with acute malaria who cannot take medication by mouth, rectal artesunate plus referral differs from rectal placebo plus referral in terms of death or permanent disability.
Ethics approval(s)	Ethics approval received on the 19th April 1999.
Health condition(s) or problem(s) studied	Malaria
Intervention	The sample size determination in the protocol specified that a total of 10,000 non per os patients would need to be randomised in order to detect a reduction of mortality from 5% to 3%. Individual patients will be randomised to receive either AS suppository (intervention group) or placebo (comparator group). Patients in both groups will then be referred (and offered transport) immediately to the nearest hospital/health centre.
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Artesunate (AS)
Primary outcome measure(s)	1. Number of relevant deaths in the intervention and control arm assessed 7 - 30 days after enrolment (relevant defined as malaria positive patients in whom the death was probably/definitely preventable by the intervention) 2. Number of individuals with serious neurological disability in the intervention and control arms assessed at 7 - 30 days following enrolment in the study. Neurological disability defined as the development of new problems with feeding, walking, talking, sitting, sight, hearing, playing, balance and behaviour
Key secondary outcome measure(s)	1. Number of deaths in the intervention and control arm assessed 7 - 30 days following enrolment in the study 2. Number of cases of neurological disability in the intervention and control arms assessed at 7 - 30 days following enrolment in the study 3. Number of cases of neurological disability in malaria smear positive patients in the intervention and control arms assessed at 7 - 30 days following enrolment in the study 4. Number of cases of neurological disability in children in the intervention and control arms assessed at 7 - 30 days following enrolment in the study 5. Number of cases of neurological disability in pregnant women in the intervention and control arms assessed at 7 - 30 days following enrolment in the study 6. Number of deaths and neurological sequelae in the intervention and control arm in malaria smear positive patients who survived at least 8 hours but died before 7 days after enrolment in the study
Completion date	19/04/2001

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	71 Months
Sex
Key inclusion criteria	1. Non per os children presenting to a peripheral health unit or traditional healer with clinicallly suspected P. falciparum malaria 2. Children from 6 months up to the age of 71 months old 3. Clinical diagnosis of probable P. falciparum malaria based on history from the parent/guardian and assessment of the Field Worker 4. Presence of one or more of the following conditions: 4.1. Repeated vomiting (defined as more than three episodes immediately after feeding in the previous 24 hours) 4.2. Inability to eat, drink or suck 4.3. Recurrent convulsions (defined as at least two fits in the previous 24 hours) 4.4. Altered consciousness (obtunded response to painful stimuli, coma, altered behaviour) 4.5. So weak that cannot sit/stand/walk unaided and so cannot take oral medication 5. Consent by patient or parent/guardian (if patient younger than 18) 6. Community informed consent - at the start of the study in that area, community consent to the project would have been obtained
Key exclusion criteria	Ability to take an oral medication.
Date of first enrolment	19/04/1999
Date of final enrolment	19/04/2001

Locations

Countries of recruitment

Ghana
Switzerland

Study participating centre

20, Avenue Appia

Geneva-27
CH 1211
Switzerland

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/02/2009		Yes	No