NCT00158574

Brief Summary

Malaria and anaemia are major causes of morbidity and mortality in children in sub-Saharan Africa. Administration of three courses of sulfadoxine/pyrimethamine (SP) as intermittent preventive treatment (IPTi) to infants when they receive EPI vaccines reduced the incidence of malaria and anaemia in infants in an area with low SP resistance, low transmission pressure and high bednet use. However, it is not clear whether this observation can be generalised to areas with high transmission and high SP resistance. The mechanism of the protective effect of IPTi is unclear. There is an urgent need to identify other anti-malarial drugs that could be used for IPTi instead of SP. This study objectives are:

  1. 1.Identification of a drug that could be used safely and effectively for IPTi instead of SP in areas, such as north eastern Tanzania, where there is a high level of resistance to SP and amodiaquine.
  2. 2.Determination of whether a short acting antimalarial drug (Lapdap) is as effective as a long acting drug (mefloquine) when used for IPTi.
  3. 3.Investigation of the effect of the intensity of transmission on the requirements for a long or short acting drug for IPTi.
  4. 4.Assessment of the effect of IPTi on the development of clinical immunity in children in low and high transmission areas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,419

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

3.2 years

First QC Date

September 8, 2005

Last Update Submit

January 11, 2017

Conditions

Malaria

Keywords

intermittent preventive treatmentmalariaefficacysafetydrug options

Outcome Measures

Primary Outcomes (1)

  • 1. Incidence of clinical malaria: [(history of fever during previous 2 days or axillary temperature >37.5ÂșC) + parasitaemia of any density + absence of any other obvious causes of fever] during the period of 3-11 months of age

    3-11 months of age

Secondary Outcomes (5)

  • 1.Mean Hb at 10-12 months of age (one month after the third course of IPTi)

    10-12 months of age

  • 2.Incidence of severe anaemia (Hb <7 g/dl) during the period of 3-11 months of age

    3-11 months of age

  • 3.Prevalence of parasitaemia at 10-12 months of age (one month after the third course of IPTi)

    10-12 months of age

  • 4.Incidence of clinical malaria [as defined above] during the period of 12-23 months of age.

    12-23 months of age

  • 5.Level and repertoires of plasma antibodies to Plasmodium falciparum variant surface antigen (anti-VSA antibodies) at 10 and 18 months of age.

    10 and 18 months of age

Study Arms (4)

Placebo

PLACEBO COMPARATOR

IPTi placebo

Drug: Placebo

Sulphadoxine-pyrimethamine

EXPERIMENTAL

IPTi SP

Drug: sulphadoxine-pyrimethamineDrug: Sulphadoxine-pryrimethamine

Mefloquine

EXPERIMENTAL
Drug: mefloquineDrug: IPTi mefloquine

Chlorproguanil dapsone

EXPERIMENTAL
Drug: Chlorproguanil-dapsoneDrug: Chlorproguanil dapsone

Interventions

sulphadoxine-pyrimethamineDRUG
Also known as: Fansidar
Sulphadoxine-pyrimethamine
mefloquineDRUG
Also known as: Larium
Mefloquine
Chlorproguanil-dapsoneDRUG
Also known as: Lapdap
Chlorproguanil dapsone
PlaceboDRUG

Placebo

Placebo
Sulphadoxine-pryrimethamineDRUG

IPTi doses 1 and 2, at ages 2 and 3 months, sulphadoxine 250mg, pyrimethamine 12.5mg IPTi doses 3, at 9 months of age, sulphadoxine 500mg, pyrimethamine 25mg

Also known as: Fansidar
Sulphadoxine-pyrimethamine
IPTi mefloquineDRUG

IPTi doses 1 \& 2 at ages 2 \& 3 months, mefloquine 125mg IPTi dose 3 at 9 months, mefloquine 250mg

Also known as: Larium
Mefloquine
Chlorproguanil dapsoneDRUG

IPTi doses 1 and 2 at ages 2 and 3 months, doses 15mg chlorproguanil and 18.75mg dapsone IPTi dose 3 at 9 months of age, doses 22.5mg chlorproguanil and 28.13mg dapsone

Also known as: Lapdap
Chlorproguanil dapsone

Eligibility Criteria

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

You may not qualify if:

  • Infants having any of the following conditions will be excluded: (1) history of allergy to study drugs; (2) history of convulsions; (3) clinical features of severe malnutrition or chronic illness including infants with signs of AIDS \[HIV prevalence in women of reproductive age in the study area was 11.5% in 1999\]39 (4) plans to leave the study area before 12 months of age.(5) weighs \<4.5 kgs (6) caretaker declines to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health, Korogwe and Same District MCH clinics

Tanga, Tanga and Kilimanjaro, Tanzania

Location

Related Publications (2)

  • Cairns M, Gosling R, Carneiro I, Gesase S, Mosha JF, Hashim R, Kaur H, Lemnge M, Mosha FW, Greenwood B, Chandramohan D. Duration of protection against clinical malaria provided by three regimens of intermittent preventive treatment in Tanzanian infants. PLoS One. 2010 Mar 1;5(3):e9467. doi: 10.1371/journal.pone.0009467.

    PMID: 20209126DERIVED

  • Gosling RD, Gesase S, Mosha JF, Carneiro I, Hashim R, Lemnge M, Mosha FW, Greenwood B, Chandramohan D. Protective efficacy and safety of three antimalarial regimens for intermittent preventive treatment for malaria in infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Oct 31;374(9700):1521-32. doi: 10.1016/S0140-6736(09)60997-1. Epub 2009 Sep 16.

    PMID: 19765815DERIVED

MeSH Terms

Conditions

Malaria

Interventions

fanasil, pyrimethamine drug combinationMefloquinechloroguanil, dapsone drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

QuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Roly Gosling, MBChB, MRCP

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR

  • Daniel Chandramohan, MBBS,PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Brian Greenwood, FRCP, FRS

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2005

Primary Completion

April 1, 2008

Study Completion

June 1, 2008

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

TA(1)