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Recruiting NCT06122259

Febrile Illness in Guinea

— Observational Febrile Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Febrile Illness. Basic parameters: from 2 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Guinea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea

Overview

To date, the underlying causes of community-acquired fever, particularly non-malarial fever, are insufficiently documented in Guinea. Moreover, diagnostic capacity is limited, leading to inadequate prescription of antibiotics and antimalarials, as well as substantial delay in outbreak recognition. Thus, the investigators undertook a prospective observational multi-centric cohort study of febrile patients presenting at the emergency and outpatient department of selected health centers, districts and regional hospitals in four ecologically distinct sentinel health districts in Guinea.

Primary outcome measures

  • Pattern of symptoms and laboratory results at presentation and during follow-up [Time frame: Day 0 and day 21]
  • Syndromic and/or etiologic diagnoses as established at day 21 [Time frame: Day 0]
  • Pattern and duration of antibiotic use (and other treatments) [Time frame: Day 0]
  • Immediate or secondary hospital admissions and of secondary/unscheduled visits [Time frame: Day 0 and day 21]
  • Participants alive (with or without symptoms) or dead at day 21. [Time frame: Day 21]
Secondary outcome measures (4)
  • White blood cells and C-reactive protein levels at baseline and association with syndromic/etiologic diagnoses and with patient outcome at day 21 [Time frame: Day 0]
  • Association of seasonal, geographical, demographic, clinical and first-line laboratory variables (malaria RDT and smear, biochemistry) with presenting syndromes/main etiologies [Time frame: Day 0]
  • Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors [Time frame: Day 0]
  • Cases fulfilling any of the case definitions of the 20 epidemic-prone infections under surveillance as compared to the final diagnosis and proportion of them timely reported to health authorities [Time frame: Day 0]

Eligibility criteria

Inclusion criteria

  • Age ≥2 months old
  • Documented fever (axillary temperature >37.5°C) at presentation or fever reported within the prior 24 hours
  • Availability for follow-up for 21 days
  • Willingness and ability of the patient or culturally acceptable representative to give informed consent for participation in the study

Exclusion criteria

  • History of hospitalization (for > 48 hours within the last 14 days) at any health facility

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Guinea · 1 center
  • Centre National de Formation et de Recherche en Santé Rurale — Maférinya

Publications

  • World health organization. The WHO AWaRe (Access, Watch, Reserve) antibiotic book. WHO. 2022. https://www.who.int/publications/i/item/9789240062382. Accessed 11 Dec 2022
  • Crump JA, Kirk MD. Estimating the Burden of Febrile Illnesses. PLoS Negl Trop Dis. 2015 Dec 3;9(12):e0004040. doi: 10.1371/journal.pntd.0004040. eCollection 2015 Dec. No abstract available. PMID 26633014
  • Roddy P, Dalrymple U, Jensen TO, Dittrich S, Rao VB, Pfeffer DA, Twohig KA, Roberts T, Bernal O, Guillen E. Quantifying the incidence of severe-febrile-illness hospital admissions in sub-Saharan Africa. PLoS One. 2019 Jul 25;14(7):e0220371. doi: 10.1371/journal.pone.0220371. eCollection 2019. PMID 31344116
  • Carugati M, Zhang HL, Kilonzo KG, Maze MJ, Maro VP, Rubach MP, Crump JA. Predicting Mortality for Adolescent and Adult Patients with Fever in Resource-Limited Settings. Am J Trop Med Hyg. 2018 Nov;99(5):1246-1254. doi: 10.4269/ajtmh.17-0682. PMID 30226134
  • Alegana VA, Maina J, Ouma PO, Macharia PM, Wright J, Atkinson PM, Okiro EA, Snow RW, Tatem AJ. National and sub-national variation in patterns of febrile case management in sub-Saharan Africa. Nat Commun. 2018 Nov 26;9(1):4994. doi: 10.1038/s41467-018-07536-9. PMID 30478314
  • Maze MJ, Bassat Q, Feasey NA, Mandomando I, Musicha P, Crump JA. The epidemiology of febrile illness in sub-Saharan Africa: implications for diagnosis and management. Clin Microbiol Infect. 2018 Aug;24(8):808-814. doi: 10.1016/j.cmi.2018.02.011. Epub 2018 Feb 15. PMID 29454844
  • Prasad N, Murdoch DR, Reyburn H, Crump JA. Etiology of Severe Febrile Illness in Low- and Middle-Income Countries: A Systematic Review. PLoS One. 2015 Jun 30;10(6):e0127962. doi: 10.1371/journal.pone.0127962. eCollection 2015. PMID 26126200
  • Steketee RW, Choi M, Linn A, Florey L, Murphy M, Panjabi R. World Malaria Day 2021: Commemorating 15 Years of Contribution by the United States President's Malaria Initiative. Am J Trop Med Hyg. 2021 Apr 23;104(6):1955-1959. doi: 10.4269/ajtmh.21-0432. PMID 33891560

Identifiers

NCT: NCT06122259 · IRB/RR/AC/041_1616/22_ITM · 139/CNERS/23 · IRB/RR/AC/041_1616/22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗