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

Fever Clinical Trial

Official title:

Universal Versus Conditional Follow Up for Children With Unclassified Fever at the Community Level: A Cluster-Randomized, Community-based, Non-Inferiority Trial in Kalemie, Democratic Republic of Congo (DRC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595827
• Other study ID #: 68295
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2015
• Last updated: February 20, 2017
• Start date: October 9, 2015
• Est. completion date: December 5, 2016

Study information

• Verified date: February 2017
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Fevers in childhood are common and usually self resolve. In rural Democratic Republic of Congo (and many other settings), when a febrile child presents to a community health worker (CHW), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs, according to World Health Organization (WHO) guidelines for integrated Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the CHW provides an antipyretic only, sends the child home, and advises all such cases to come back in 3 days. We hypothesize, however, that health outcomes for these cases will be equivalent if the CHW advises to come back in 3 days, only if symptoms have not resolved.

To test this hypothesis, we are conducting a cluster-randomized, community-based non-inferiority trial in two zones of Kalemie, Katanga Province, Democratic Republic of Congo. In this area, the International Rescue Committee (IRC) has been supporting the training, scale-up, and rollout of community health workers who conduct iCCM as per WHO guidelines and with Ministry of Health oversight. CHWs have unique non-overlapping catchment areas, and groups of CHWs (average 5-7) are associated with health clinics. We will utilize this group structure as the unit of randomization; health clinics (and thereby, groups of CHWs) will be randomly allocated to one of two groups in terms of the advice given to caretakers of children who have no danger signs, have neither malaria, pneumonia, nor diarrhea, and are thus classified as having fever of non-identified origin.

• Group 1 (Universal follow-up): CHWs in this group will advise caretakers to follow up in 3 days

• Group 2 (Conditional follow-up): CHWs in this group will advise caretakers to follow up in 3 days if symptoms/signs remain the same (or worsen).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4451
• Est. completion date: December 5, 2016
• Est. primary completion date: December 5, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 60 Months

Eligibility

Inclusion Criteria:

• Agree to recruitment script provided by CHWs at the time of identification of eligible

Exclusion Criteria:

Related Conditions & MeSH terms

• Fever

Intervention

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

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	International Rescue Committee, Kalemie Office	Kalemie	Katanga

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Centers for Disease Control and Prevention, International Rescue Committee, University Research Co, LLC

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical failure at 7 days	If the child has fever, has a CHW-treatable condition (pneumonia, malaria, or diarrhea), or is referred for care at the Day 7 visit, the child has met the definition of the primary outcome	1 week