Febrile Illness in Guinea

Febrile Illness Clinical Trial

— MuSIFe  

Official title:

Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122259
• Other study ID #: IRB/RR/AC/041_1616/22_ITM
• Secondary ID: 139/CNERS/23IRB/
• Status: Recruiting
• Start date: March 27, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Centre National de Formation et de Recherche en Sante Rurale
• Contact: Karifa Kourouma, MD, MSc
• Phone: +224-628-765-320
• Email: KKourouma[@]maferinyah.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Febrile Illness
• Fever
• Hyperthermia

Locations

Country	Name	City	State
Guinea	Centre National de Formation et de Recherche en Santé Rurale	Maférinya	Forécariah

Sponsors (2)

Lead Sponsor	Collaborator
Centre National de Formation et de Recherche en Sante Rurale	Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Guinea, 

References & Publications (19)

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/s41467-018-075 — View Citation

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. d — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 unc — View Citation

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. — View Citation

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.2018.04.01 — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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/j — View Citation

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 Ou — View Citation

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. — View Citation

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 — View Citation

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: 10.1 — View Citation

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 The — View Citation

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)

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

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of symptoms and laboratory results at presentation and during follow-up	Proportion will be estimated	Day 0 and day 21
Primary	Syndromic and/or etiologic diagnoses as established at day 21	Proportion will be estimated	Day 0
Primary	Pattern and duration of antibiotic use (and other treatments)	Proportion and mean or median will be estimated	Day 0
Primary	Immediate or secondary hospital admissions and of secondary/unscheduled visits	Proportion will be estimated	Day 0 and day 21
Primary	Participants alive (with or without symptoms) or dead at day 21.	Survival or mortality rate will be estimated	Day 21
Secondary	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	Day 0
Secondary	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	Day 0
Secondary	Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors	Proportions will be estimated	Day 0
Secondary	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	Day 0