NCT00206739

Brief Summary

The purpose of this study is to assess the effectiveness of Intermittent Preventive Treatment in Infants (IPTi) with Sulfadoxine-Pyrimethamine to reduce the numbers of malaria attacks, episodes of anemia, and the overall morbidity and mortality

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,070

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Typical duration 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

January 1, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

March 30, 2010

Status Verified

September 1, 2005

Enrollment Period

2.7 years

First QC Date

September 13, 2005

Last Update Submit

March 29, 2010

Conditions

MalariaAnemia

Keywords

MalariaAnemiaIPTiIntermittent Preventive Treatment in InfantsSulfadoxine-PyrimethamineChemoprophylaxisGhana

Outcome Measures

Primary Outcomes (3)

  • • Efficacy of an extended intermittent treatment with sulfadoxine-pyrimethamine for the control of clinical malaria and anemia (proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 21 months of life)

  • • Determination of the rate of clinical malaria and anemia after suspending an extended intermittent treatment for analysis of possible rebound effects

  • • Evaluation of safety and adverse effects of the administration of single doses of sulfadoxine-pyrimethamine in infants and children

Secondary Outcomes (7)

  • • Rate and time points of hospitalizations with anemia, malaria or other diseases

  • • Rate and time points of severe anemia episodes

  • • Proportion and rates of children with one or more episodes of malaria or anemia in the age of 3 to 12 months of life

  • • Antibody responses against parasite antigens

  • • Multiplicity of P. falciparum infections

  • +2 more secondary outcomes

Interventions

Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)DRUG

Eligibility Criteria

Age2 Months - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent by parent/guardian (written or oral)
  • Permanent residentship in the study area
  • Age of 3 months +/-4 weeks

You may not qualify if:

  • Hypersensitivity to sulfonamides or pyrimethamine (skin rashes, evidence of hemolysis including dark urine and/or purpura, presumptive signs of bone marrow depression such as sore throat and/or mouth ulcers)
  • Other severe adverse events related to pyrimethamine-sulfadoxine application
  • Signs of severe hepatic or renal dysfunction not due to malaria
  • Other reasons after decision of the study physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kumasi Centre for Collaborative Research in Tropical Medicine

Kumasi, Ashanti Region, Ghana

Location

Related Publications (6)

  • 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

  • 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

  • Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60. doi: 10.1016/s0140-6736(03)13504-0.

    PMID: 12788572BACKGROUND

  • Verhoef H, West CE, Nzyuko SM, de Vogel S, van der Valk R, Wanga MA, Kuijsten A, Veenemans J, Kok FJ. Intermittent administration of iron and sulfadoxine-pyrimethamine to control anaemia in Kenyan children: a randomised controlled trial. Lancet. 2002 Sep 21;360(9337):908-14. doi: 10.1016/S0140-6736(02)11027-0.

    PMID: 12354473BACKGROUND

  • 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

  • Kobbe R, Adjei S, Kreuzberg C, Kreuels B, Thompson B, Thompson PA, Marks F, Busch W, Tosun M, Schreiber N, Opoku E, Adjei O, Meyer CG, May J. Malaria incidence and efficacy of intermittent preventive treatment in infants (IPTi). Malar J. 2007 Dec 9;6:163. doi: 10.1186/1475-2875-6-163.

    PMID: 18067679DERIVED

Related Links

MeSH Terms

Conditions

MalariaAnemia

Interventions

SulfadoxinePyrimethamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ohene Adjei, Prof. Dr.

    Kumasi Centre for Collaborative Research in Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Jürgen May, PD Dr.

    Bernhard Nocht Institute for Tropical Medicine Hamburg, Infection Epidemiology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2003

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

March 30, 2010

Record last verified: 2005-09

Locations

GH(1)