Contact information
Type
Scientific
Primary contact
Dr Melba Gomes
ORCID ID
Contact details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3813
gomesm@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
990354
Study information
Scientific title
Acronym
Study hypothesis
To establish whether preventive treatment given at EPI prevented either severe anaemia or malaria.
Ethics approval
Ethics approval received on the 15th December 1999.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Sulphadoxine-Pyrimethamine (SP)
Primary outcome measures
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 trial start date
15/12/1999
Overall trial end date
15/12/2001
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
900 infants randomised
Participant 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
Recruitment start date
15/12/1999
Recruitment end date
15/12/2001
Locations
Countries of recruitment
Kenya
Trial participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Sponsor details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary