Phase IV rectal artesunate clinical trial in the Kassena Nankana District of Ghana
| ISRCTN | ISRCTN46343627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46343627 |
| Secondary identifying numbers | N/A |
- 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
Scientific
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 3813 |
|---|---|
| gomesm@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Artesunate (AS) |
| Primary outcome measure | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 19/04/1999 |
| Completion date | 19/04/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 71 Months |
| Sex | Not Specified |
| Target number of participants | In this trial, it is not the number of patients recruited but the number of deaths that determine the statistical power of such a trial. |
| 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
CH 1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation
Research organisation
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| Website | http://www.who.int/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
European Commission (Belgium)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
WHO Global Malaria Programme
No information available
US Agency for International Development (USAID) (USA)
No information available
Irish Aid (Ireland)
No information available
Karolinska Institutet (Sweden)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Karolinska Institute, KI
- Location
- Sweden
Sall Family Foundation (USA)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United States of America
University of Oxford Clinical Trial Service Unit (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/02/2009 | Yes | No |
