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

NCT02595827 | Completed Phase 3

• 1 other identifier: 68295
• Study Type: interventional
• Target: 4,451
• Locations: 1 country
• Sites: 1

Brief 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

Fever

Keywords

Pediatrics; Epidemiology; Fever; Democratic Republic of the Congo; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Universal

NO INTERVENTION

In this group, caretakers of children will receive the standard advice under current iCCM guidelines in DRC. Specifically, the CHW will advise that the child come back in 2-3 days.

Conditional

ACTIVE COMPARATOR

In this Conditional Advice group, caretakers will be given advice that is modified from the current iCCM guidelines. Specifically, the CHW will advise that the child come back in 2-3 days if the child's symptoms continue.

Other: Conditional Advice

Interventions

Conditional Advice OTHER

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

Conditional

Eligibility Criteria

• Age: 2 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• International Rescue Committee: collaborator
• University Research Co, LLC: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

International Rescue Committee, Kalemie Office

Kalemie, Katanga, Democratic Republic of the Congo

Location

Related Publications (2)

• Mullany LC, van Boetzelaer EW, Gutman JR, Steinhardt LC, Ngoy P, Barbera Lainez Y, Wittcoff A, Harvey SA, Ho LS. Universal versus conditional day 3 follow-up for children with non-severe unclassified fever at the community level in the Democratic Republic of the Congo: A cluster-randomized, community-based non-inferiority trial. PLoS Med. 2018 Apr 17;15(4):e1002552. doi: 10.1371/journal.pmed.1002552. eCollection 2018 Apr.

  PMID: 29664951 DERIVED

• van Boetzelaer E, Ho LS, Gutman JR, Steinhardt LC, Wittcoff A, Barbera Y, Ngoy P, Harvey SA, Mullany LC. Universal versus conditional three-day follow up visit for children with uncomplicated fever at the community level: design of a cluster-randomized, community-based, non-inferiority trial in Tanganyika, Democratic Republic of Congo. BMC Pediatr. 2017 Jan 26;17(1):36. doi: 10.1186/s12887-017-0792-1.

  PMID: 28122542 DERIVED

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luke C Mullany, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: October 9, 2015
• Primary Completion: December 5, 2016
• Study Completion: December 5, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

DE (1)