Febrile Illness in Guinea

NCT06122259 | Recruiting

• 3 other identifiers: IRB/RR/AC/041_1616/22_ITM139/CNERS/23IRB/RR/AC/041_1616/22
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Febrile Illness

Outcome Measures

Primary Outcomes (5)

• Pattern of symptoms and laboratory results at presentation and during follow-up

  Proportion will be estimated

  Day 0 and day 21

• Syndromic and/or etiologic diagnoses as established at day 21

  Proportion will be estimated

  Day 0

• Pattern and duration of antibiotic use (and other treatments)

  Proportion and mean or median will be estimated

  Day 0

• Immediate or secondary hospital admissions and of secondary/unscheduled visits

  Proportion will be estimated

  Day 0 and day 21

• Participants alive (with or without symptoms) or dead at day 21.

  Survival or mortality rate will be estimated

  Day 21

Secondary Outcomes (4)

• White blood cells and C-reactive protein levels at baseline and association with syndromic/etiologic diagnoses and with patient outcome at day 21

  Day 0

• Association of seasonal, geographical, demographic, clinical and first-line laboratory variables (malaria RDT and smear, biochemistry) with presenting syndromes/main etiologies

  Day 0

• Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors

  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

  Day 0

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Febrile patients presenting with documented fever (\> 37.5°C, axillary temperature) or reporting fever within the prior 24 hours (≤37.5°C, axillary temperature) at the emergency or outpatient department of the selected health facilities.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre National de Formation et de Recherche en Sante Rurale: lead
• Institute of Tropical Medicine, Belgium: collaborator

Study Sites (1)

Centre National de Formation et de Recherche en Santé Rurale

Maférinya, Forécariah, 2649, Guinea

RECRUITING

Related Publications (19)

• 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

  BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Iroh Tam PY, Obaro SK, Storch G. Challenges in the Etiology and Diagnosis of Acute Febrile Illness in Children in Low- and Middle-Income Countries. J Pediatric Infect Dis Soc. 2016 Jun;5(2):190-205. doi: 10.1093/jpids/piw016. Epub 2016 Apr 7.

  PMID: 27059657 RESULT

• Boillat-Blanco N, Mbarack Z, Samaka J, Mlaganile T, Kazimoto T, Mamin A, Genton B, Kaiser L, D'Acremont V. Causes of fever in Tanzanian adults attending outpatient clinics: a prospective cohort study. Clin Microbiol Infect. 2021 Jun;27(6):913.e1-913.e7. doi: 10.1016/j.cmi.2020.08.031. Epub 2020 Sep 4.

  PMID: 32896654 RESULT

• D'Acremont V, Kilowoko M, Kyungu E, Philipina S, Sangu W, Kahama-Maro J, Lengeler C, Cherpillod P, Kaiser L, Genton B. Beyond malaria--causes of fever in outpatient Tanzanian children. N Engl J Med. 2014 Feb 27;370(9):809-17. doi: 10.1056/NEJMoa1214482.

  PMID: 24571753 RESULT

• Wang H, Zhao J, Xie N, Wang W, Qi R, Hao X, Liu Y, Sevalie S, Niu G, Zhang Y, Wu G, Lv X, Chen Y, Ye Y, Bi S, Moseray M, Cellessy S, Kalon K, Baika DI, Luo Q. A Prospective Study of Etiological Agents Among Febrile Patients in Sierra Leone. Infect Dis Ther. 2021 Sep;10(3):1645-1664. doi: 10.1007/s40121-021-00474-y. Epub 2021 Jun 26.

  PMID: 34173960 RESULT

• Muianga A, Pinto G, Massangaie M, Ali S, Oludele J, Tivane A, Falk KI, Lagerqvist N, Gudo ES. Antibodies Against Chikungunya in Northern Mozambique During Dengue Outbreak, 2014. Vector Borne Zoonotic Dis. 2018 Aug;18(8):445-449. doi: 10.1089/vbz.2017.2261. Epub 2018 May 7.

  PMID: 29733254 RESULT

• Ushijima Y, Abe H, Nguema Ondo G, Bikangui R, Massinga Loembe M, Zadeh VR, Essimengane JGE, Mbouna AVN, Bache EB, Agnandji ST, Lell B, Yasuda J. Surveillance of the major pathogenic arboviruses of public health concern in Gabon, Central Africa: increased risk of West Nile virus and dengue virus infections. BMC Infect Dis. 2021 Mar 17;21(1):265. doi: 10.1186/s12879-021-05960-9.

  PMID: 33731022 RESULT

• World Health Organization. Integrated Management of Childhood Illness (IMCI)_chart booklet. Geneva; 2014. Link: https://www.who.int/publications/m/item/integrated-management-of-childhood-illness---chart-booklet-(march-2014)

  RESULT

• Shao AF, Rambaud-Althaus C, Samaka J, Faustine AF, Perri-Moore S, Swai N, Kahama-Maro J, Mitchell M, Genton B, D'Acremont V. New Algorithm for Managing Childhood Illness Using Mobile Technology (ALMANACH): A Controlled Non-Inferiority Study on Clinical Outcome and Antibiotic Use in Tanzania. PLoS One. 2015 Jul 10;10(7):e0132316. doi: 10.1371/journal.pone.0132316. eCollection 2015.

  PMID: 26161535 RESULT

• Guillebaud J, Bernardson B, Randriambolamanantsoa TH, Randrianasolo L, Randriamampionona JL, Marino CA, Rasolofo V, Randrianarivelojosia M, Vigan-Womas I, Stivaktas V, Venter M, Piola P, Heraud JM. Study on causes of fever in primary healthcare center uncovers pathogens of public health concern in Madagascar. PLoS Negl Trop Dis. 2018 Jul 16;12(7):e0006642. doi: 10.1371/journal.pntd.0006642. eCollection 2018 Jul.

  PMID: 30011274 RESULT

• van Griensven J, Cnops L, De Weggheleire A, Declercq S, Bottieau E. Point-of-Care Biomarkers to Guide Antibiotic Prescription for Acute Febrile Illness in Sub-Saharan Africa: Promises and Caveats. Open Forum Infect Dis. 2020 Jun 30;7(8):ofaa260. doi: 10.1093/ofid/ofaa260. eCollection 2020 Aug.

  PMID: 32818139 RESULT

• Keitel K, D'Acremont V. Electronic clinical decision algorithms for the integrated primary care management of febrile children in low-resource settings: review of existing tools. Clin Microbiol Infect. 2018 Aug;24(8):845-855. doi: 10.1016/j.cmi.2018.04.014. Epub 2018 Apr 21.

  PMID: 29684634 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

A venous blood volume of up to 10.5 ml will be collected from all participants to meet needs for routine clinical laboratory analysis and monitoring as well as study related laboratory analysis and sample storage needs at inclusion.

Study Officials

• Emmanuel Bottieau, MD, MSc, PhD

  Institute of Tropical Medicine, Antwerp, Belgium

  STUDY DIRECTOR

Central Study Contacts

Karifa Kourouma, MD, MSc

CONTACT

+224-628-765-320; KKourouma@maferinyah.org

Alexandre Delamou, MD, MPH, PhD

CONTACT

+224-628-594-765; adelamou@maferinyah.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 8, 2023
• Study Start: March 27, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Yet to be finalized.
• Access Criteria: Yet to be finalized. However, investigators are opened to collaborate on that data that will be generated.

Locations

GU (1)