NCT00168532

Brief Summary

Objective It is the objective to test whether the use of prophylactic antibiotics in measles infection will reduce the incidence of post-measles pneumonia and/or admissions to hospital with 50%. The possible impact on other complications of severe measles will also be measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
218

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 1998

Typical duration for phase_3

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, 1998

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2001

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

February 26, 2008

Status Verified

February 1, 2008

Enrollment Period

3.8 years

First QC Date

September 9, 2005

Last Update Submit

February 25, 2008

Conditions

Post-Measles PneumoniaMeasles

Keywords

Prophylactic antibioticsMeaslesPneumoniaPost-measles pneumoniaLow income countryGuinea-BissauBandim Health Project

Outcome Measures

Primary Outcomes (2)

  • Post-measles pneumonia

  • Admission to hospital

Secondary Outcomes (7)

  • Weight gain or loss during the first month of infection

  • Diarrhoea

  • Severe fever

  • Oral thrush

  • Stomatitis

  • +2 more secondary outcomes

Interventions

Sulfamethoxazole-TrimethoprimDRUG

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical diagnosis of probable measles in the prodromal phase or within the first seven days of the onset of the rash

You may not qualify if:

  • Pregnant and nursing women
  • Children less than 2 months old
  • Children who need urgent referral to the hospital, children with bacterial infections of the lung, or children with another bacterial infection requiring systemic antibiotic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project

Bissau, Apartado 861, 1004 Bissau Codex, Guinea-Bissau

Location

Related Publications (1)

  • Garly ML, Bale C, Martins CL, Whittle HC, Nielsen J, Lisse IM, Aaby P. Prophylactic antibiotics to prevent pneumonia and other complications after measles: community based randomised double blind placebo controlled trial in Guinea-Bissau. BMJ. 2006 Dec 16;333(7581):1245. doi: 10.1136/bmj.38989.684178.AE. Epub 2006 Oct 23.

    PMID: 17060336DERIVED

Related Links

MeSH Terms

Conditions

MeaslesPneumonia

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • PETER AABY, MSc, Dr Med

    Bandim Health Project

    STUDY DIRECTOR

  • MAY-LILL GARLY, PHD, DTM&H

    Bandim Health Project

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

January 1, 1998

Primary Completion

October 1, 2001

Study Completion

October 1, 2001

Last Updated

February 26, 2008

Record last verified: 2008-02

Locations

GU(1)