Condition category
Infections and Infestations
Date applied
01/02/2006
Date assigned
01/02/2006
Last edited
02/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.who.int/

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

Publication citations

Additional files

Editorial Notes