NCT02595827

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

Completed Phase 3 Last updated 23 February 2017

What this trial tests

Phase 3 trial testing Conditional Advice in Fever in 4,451 participants. Completed in 5 December 2016.

Timeline

9 October 2015

Primary endpoint
5 December 2016

5 December 2016

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	4,451
Start date	9 October 2015
Primary completion	5 December 2016
Estimated completion	5 December 2016
Sites	1 location across Democratic Republic of the Congo

Drugs / interventions tested

• Conditional Advice

Conditions studied

• Fever — all drugs for Fever →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

Adults 2 Months to 60 Months, any sex, with Fever. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   van Boetzelaer E, Ho LS, Gutman JR, Steinhardt LC, et al · · 2017 · cited 3× · PMID 28122542 · DOI 10.1186/s12887-017-0792-1
2. 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.
   Mullany LC, van Boetzelaer EW, Gutman JR, Steinhardt LC, et al · · 2018 · cited 1× · PMID 29664951 · DOI 10.1371/journal.pmed.1002552