Randomised placebo controlled trial of intermittent malaria treatment through the Expanded Programme on Immunisation (EPI) to prevent malaria/anaemia in infants (Kenya)
| ISRCTN | ISRCTN46236868 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46236868 |
| Secondary identifying numbers | 990354 |
- Submission date
- 01/02/2006
- Registration date
- 01/02/2006
- Last edited
- 19/07/2021
- 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 | Randomised placebo controlled trial of intermittent malaria treatment through the Expanded Programme on Immunisation (EPI) to prevent malaria/anaemia in infants (Kenya) |
| Study objectives | To establish whether preventive treatment given at EPI prevented either severe anaemia or malaria. |
| Ethics approval(s) | Ethics approval received on the 15th December 1999. |
| Health condition(s) or problem(s) studied | Malaria |
| Intervention | Sulphadoxine-pyrimethamine or placebo given at EPI visits DPT2, DPT3 and measles. Collection of sera to establish impact (if any) upon EPI antigens. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sulphadoxine-Pyrimethamine (SP) |
| Primary outcome measure | 1. Effectiveness of intermittent malaria treatment of infants with SP (versus placebo) within the Kenya EPI schedule in preventing severe anaemia and malaria 2. Assessment of serological responses to EPI vaccines in children receiving SP versus those receiving placebo for SP |
| Secondary outcome measures | 1. Determine whether intermittent malaria treatment results in a rebound effect of more episodes of malaria after treatment is stopped 2. Determine whether intermittent malaria treatment results in improved growth of infants |
| Overall study start date | 15/12/1999 |
| Completion date | 15/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 900 infants randomised |
| Key inclusion criteria | 1. Infants of both gender whose parents or guardians give consent and agree to participate in the study for at least eighteen months 2. Infants who will be presenting to the clinic for their second Diphtheria, Pertussis, Tetanus (DPT) and second Oral Polio Vaccine (OPV) immunisations and are aged less than one |
| Key exclusion criteria | 1. Infants with known hypersensitivity to study drugs 2. Infants with congenital malformations and history of haemolytic anaemia 3. Infants with a history of blood transfusion in the previous week 4. SP treatment in the previous two weeks |
| Date of first enrolment | 15/12/1999 |
| Date of final enrolment | 15/12/2001 |
Locations
Countries of recruitment
- Kenya
- 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
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 | 15/09/2012 | 19/07/2021 | Yes | No |
Editorial Notes
19/07/2021: Publication reference added.
