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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02595827
• Date of registration: 02/11/2015
• Prospective Registration: No
• Primary sponsor: Johns Hopkins Bloomberg School of Public Health
• Public title: Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo
• Scientific 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)
• Date of first enrolment: October 9, 2015
• Target sample size: 4451
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02595827
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Congo, The Democratic Republic of the

Contacts

• Name: Luke C Mullany, PhD
• Affiliation: Johns Hopkins Bloomberg School of Public Health

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:



Age minimum: 2 Months
Age maximum: 60 Months
Gender: All

Health Condition(s) or Problem(s) studied

Fever

Intervention(s)

Other: Conditional Advice

Primary Outcome(s)

Clinical failure at 7 days [Time Frame: 1 week]

Secondary ID(s)

68295

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

International Rescue Committee

Centers for Disease Control and Prevention

University Research Co, LLC