NCT00167843

Brief Summary

The general goal of the project is to assess the infectious status and immunity of mothers and children living in a malaria region. A major part of the study involves administering an effective antimalarial, sulfadoxine-pyrimethamine (Fansidar®), to children at the same timepoints as vaccinations, i.e. at age 3, 9 and 15 months. The main objective is to study safety, efficacy, and consequences of such a strategy in particular the ability to reduce the risk of anemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,189

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_4

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

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

First QC Date

September 11, 2005

Last Update Submit

January 23, 2013

Conditions

Malaria

Keywords

MalariaAnemiaChildrenGabonIntermittent preventive treatment

Outcome Measures

Primary Outcomes (8)

  • Efficacy:

  • The proportion of children with at least one episode of anemia from 3 to 18 months of life

  • The proportion of children with at least one episode of malaria from 3 to 18 months of life

  • Safety:

  • The proportion of children with at least one episode of an adverse event

  • The proportion of children with at least one episode of a serious adverse event

  • Rebound:

  • The proportion of children with at least one episode of anemia from 18-30 months of life, the proportion of children with at least one episode of malaria from 18-30 months of life

Secondary Outcomes (10)

  • Proportion of children with at least one episode of severe anemia

  • Proportion of hospitalized children with anemia

  • Proportion of hospitalized children with malaria

  • Proportion of hospitalized children with any disease

  • Proportion of children with at least one episode of anemia from 3 to 12 months of life

  • +5 more secondary outcomes

Interventions

sulfadoxine-pyrimethamineDRUG

Eligibility Criteria

AgeUp to 5 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent
  • Permanent residence in the study area

You may not qualify if:

  • Allergy/hypersensitivity to sulfonamides or pyrimethamine
  • Signs of severe hepatic or renal dysfunction not due to malaria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Unit of the Albert Schweitzer Hospital

Lambaréné, Moyen-Ogooué Province, B.P. 118, Gabon

Location

Related Publications (10)

  • WHO. In WHO report: Fostering Development, Geneva, 1996

    BACKGROUND

  • Greenwood BM, Greenwood AM, Bradley AK, Snow RW, Byass P, Hayes RJ, N'Jie AB. Comparison of two strategies for control of malaria within a primary health care programme in the Gambia. Lancet. 1988 May 21;1(8595):1121-7. doi: 10.1016/s0140-6736(88)91949-6.

    PMID: 2896957BACKGROUND

  • Menendez C, Kahigwa E, Hirt R, Vounatsou P, Aponte JJ, Font F, Acosta CJ, Schellenberg DM, Galindo CM, Kimario J, Urassa H, Brabin B, Smith TA, Kitua AY, Tanner M, Alonso PL. Randomised placebo-controlled trial of iron supplementation and malaria chemoprophylaxis for prevention of severe anaemia and malaria in Tanzanian infants. Lancet. 1997 Sep 20;350(9081):844-50. doi: 10.1016/S0140-6736(97)04229-3.

    PMID: 9310602BACKGROUND

  • Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2.

    PMID: 11377597BACKGROUND

  • Bradley-Moore AM, Greenwood BM, Bradley AK, Bartlett A, Bidwell DE, Voller A, Kirkwood BR, Gilles HM. Malaria chemoprophylaxis with chloroquine in young Nigerian children. I. Its effect on mortality, morbidity and the prevalence of malaria. Ann Trop Med Parasitol. 1985 Dec;79(6):549-62. doi: 10.1080/00034983.1985.11811962.

    PMID: 3914860BACKGROUND

  • Diagne N, Rogier C, Sokhna CS, Tall A, Fontenille D, Roussilhon C, Spiegel A, Trape JF. Increased susceptibility to malaria during the early postpartum period. N Engl J Med. 2000 Aug 31;343(9):598-603. doi: 10.1056/NEJM200008313430901.

    PMID: 10965006BACKGROUND

  • Gabor JJ, Schwarz NG, Esen M, Kremsner PG, Grobusch MP. Dengue and chikungunya seroprevalence in Gabonese infants prior to major outbreaks in 2007 and 2010: A sero-epidemiological study. Travel Med Infect Dis. 2016 Jan-Feb;14(1):26-31. doi: 10.1016/j.tmaid.2016.01.005. Epub 2016 Jan 29.

    PMID: 26869532DERIVED

  • Grobusch MP, Gabor JJ, Aponte JJ, Schwarz NG, Poetschke M, Doernemann J, Schuster K, Koester KB, Profanter K, Borchert LB, Kurth F, Pongratz P, Issifou S, Lell B, Kremsner PG. No rebound of morbidity following intermittent preventive sulfadoxine-pyrimethamine treatment of malaria in infants in Gabon. J Infect Dis. 2009 Dec 1;200(11):1658-61. doi: 10.1086/647990.

    PMID: 19848610DERIVED

  • May J, Adjei S, Busch W, Gabor JJ, Issifou S, Kobbe R, Kreuels B, Lell B, Schwarz NG, Adjei O, Kremsner PG, Grobusch MP. Therapeutic and prophylactic effect of intermittent preventive anti-malarial treatment in infants (IPTi) from Ghana and Gabon. Malar J. 2008 Oct 1;7:198. doi: 10.1186/1475-2875-7-198.

    PMID: 18828899DERIVED

  • Grobusch MP, Lell B, Schwarz NG, Gabor J, Dornemann J, Potschke M, Oyakhirome S, Kiessling GC, Necek M, Langin MU, Klein Klouwenberg P, Klopfer A, Naumann B, Altun H, Agnandji ST, Goesch J, Decker M, Salazar CL, Supan C, Kombila DU, Borchert L, Koster KB, Pongratz P, Adegnika AA, Glasenapp Iv, Issifou S, Kremsner PG. Intermittent preventive treatment against malaria in infants in Gabon--a randomized, double-blind, placebo-controlled trial. J Infect Dis. 2007 Dec 1;196(11):1595-602. doi: 10.1086/522160. Epub 2007 Oct 25.

    PMID: 18008242DERIVED

Related Links

MeSH Terms

Conditions

MalariaAnemia

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Peter G Kremsner, MD

    Albert Schweitzer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

December 1, 2002

Study Completion

March 1, 2007

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

GA(1)