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
Protocol serial number	990354
Sponsor	UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Funder	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)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Melba Gomes
Scientific

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sulphadoxine-Pyrimethamine (SP)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	15/12/2001

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	900
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

20, Avenue Appia

Geneva-27
CH 1211
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		15/09/2012	19/07/2021	Yes	No

19/07/2021: Publication reference added.