ClinicalTrials.gg
RecruitingNCT06122259MuSIFeUpdated Nov 8, 2023

Febrile Illness in Guinea

An observational study in Febrile Illness, sponsored by Centre National de Formation et de Recherche en Sante Rurale. Recruiting at 1 site in Guinea. Open to participants aged 2 Months and older. Per ClinicalTrials.gov, last updated 2023-11-08.

Sponsored by Centre National de Formation et de Recherche en Sante Rurale · Observational

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
2 Months and older
Sex
All
01

Study 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.

02

Conditions studied

  • Febrile Illness
03

In context

Lead sponsor

Centre National de Formation et de Recherche en Sante Rurale is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 for participation in the study

Exclusion criteria

Exclusion Criteria:

  • History of hospitalization (for > 48 hours within the last 14 days) at any health facility
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Target follow-up
21 Days
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

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

    Proportion will be estimated

    Time frame: Day 0 and day 21

  2. Syndromic and/or etiologic diagnoses as established at day 21

    Proportion will be estimated

    Time frame: Day 0

  3. Pattern and duration of antibiotic use (and other treatments)

    Proportion and mean or median will be estimated

    Time frame: Day 0

  4. Immediate or secondary hospital admissions and of secondary/unscheduled visits

    Proportion will be estimated

    Time frame: Day 0 and day 21

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

    Survival or mortality rate will be estimated

    Time frame: Day 21

Secondary outcomes

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

    Mean or median level will be estimated

    Time frame: Day 0

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

    OR or RR will be estimated as appropriate

    Time frame: Day 0

  3. Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors

    Proportions will be estimated

    Time frame: Day 0

  4. 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

    Proportions will be estimated

    Time frame: Day 0

07

Study locations

1 of 1 sites recruiting
  • Centre National de Formation et de Recherche en Santé Rurale
    Maférinya, Forécariah 2649, Guinea
    Recruiting
    • Alsény Yarie Camara, MD, MPH · Contactaycamara@maferinyah.org
    • Armand Saloun Kamano, MD · Contactaskamano@maferinyah.org
    • Karifa Kourouma, MD, MSc · Principal investigator
    • Alexandre Delamou, MD, MPH, PhD · Sub investigator
    • Abdoul Habib Beavogui, MD, MSc, PhD · Sub investigator
    • Emmanuel Bottieau, MD, MSc, PhD · Sub investigator
    • Isabel Brosius, MD, MSC · Sub investigator
    • Steven Declercq, MD, MPH · Sub investigator
    • Koen Vercauteren, PharmaD, MSc, PhD · Sub investigator
    • Eugene Bangwen, MPH · Sub investigator
    • Laurens Liesenborghs, MD, MSc, PhD · Sub investigator
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 33891560 ↗
  • 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. PubMed 27059657 ↗
  • 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. PubMed 32896654 ↗
  • 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. PubMed 24571753 ↗
  • 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. PubMed 34173960 ↗
  • 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. PubMed 29733254 ↗
  • 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. PubMed 33731022 ↗
  • 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)
  • 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. PubMed 26161535 ↗
  • 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. PubMed 30011274 ↗
  • 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. PubMed 32818139 ↗
  • 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. PubMed 29684634 ↗

Individual participant data

Plan to share: Yes — This is under development and will be filled when finalized.

Supporting information: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06122259
Lead sponsor
Centre National de Formation et de Recherche en Sante Rurale
Responsible party
Karifa Kourouma (Principal Investigator, Centre National de Formation et de Recherche en Sante Rurale) — Principal investigator
First posted
Nov 8, 2023
Start date
Mar 27, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 8, 2023

Study contacts

Karifa Kourouma, MD, MSc
Contact
KKourouma@maferinyah.org
+224-628-765-320
Alexandre Delamou, MD, MPH, PhD
Contact
adelamou@maferinyah.org
+224-628-594-765
Emmanuel Bottieau, MD, MSc, PhD
study director · Institute of Tropical Medicine, Antwerp, Belgium

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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