NCT00857077

Brief Summary

Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron supplementation delivered through Expanded Programme on Immunisation vaccination clinics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,485

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

First QC Date

March 5, 2009

Last Update Submit

January 25, 2017

Conditions

AnaemiaMalaria

Keywords

incidence of anaemia

Outcome Measures

Primary Outcomes (1)

  • incidence of anaemia

Secondary Outcomes (4)

  • incidence of clinical malaria

  • incidence of severe disease and mortality

  • prevalence of anaemia and parasitaemia

  • incidence of adverse events

Study Arms (2)

1 Placebo

PLACEBO COMPARATOR
Drug: Placebo

2 Sulfadoxine-pyrimethamine (SP)

ACTIVE COMPARATOR
Drug: Sulfadoxine-pyrimethamine

Interventions

Sulfadoxine-pyrimethamineDRUG
2 Sulfadoxine-pyrimethamine (SP)
PlaceboDRUG
1 Placebo

Eligibility Criteria

Age2 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All infants living in study clusters without a history of allergy to sulfadoxine-pyrimethamine were eligible for enrollment in the study.

You may not qualify if:

  • History of allergy to sulfadoxine-pyrimethamine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navrongo Health Research Centre

Navrongo, Upper East Region, Ghana

Location

Related Publications (1)

  • Chandramohan D, Owusu-Agyei S, Carneiro I, Awine T, Amponsa-Achiano K, Mensah N, Jaffar S, Baiden R, Hodgson A, Binka F, Greenwood B. Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana. BMJ. 2005 Oct 1;331(7519):727-33. doi: 10.1136/bmj.331.7519.727.

    PMID: 16195288RESULT

MeSH Terms

Conditions

AnemiaMalaria

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Daniel Chandramohan, MD; PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Brian Greenwood, MD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

September 1, 2000

Study Completion

June 1, 2004

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

GH(1)