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Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo

NCT02595827 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4451

Last updated 2017-02-23

No results posted yet for this study

Summary

Providers in integrated Community Case Management (iCCM) programs in low resource settings often see children without any danger signs, presenting with fever but not having pneumonia, malaria, or diarrhea. These children are sent home (often with analgesic only), and caretakers are advised to return in 2 or 3 days. In this study, we are evaluating if conditional return advice (i.e. return in 2 or 3 day only if your child is still sick") results in the same proportion of children remaining with fever one week after identification, as the current universal return advice.

Conditions

Interventions

OTHER

Conditional Advice

Caretakers are told to return in 2-3 only (Conditional Advice) if the child's symptoms continue.

Sponsors & Collaborators

  • International Rescue Committee

    collaborator OTHER

  • University Research Co, LLC

    collaborator INDUSTRY

  • Centers for Disease Control and Prevention

    collaborator FED

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Luke C Mullany, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-09
Primary Completion
2016-12-05
Completion
2016-12-05

Countries

  • Democratic Republic of the Congo

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02595827 on ClinicalTrials.gov