Febrile IllnessMuSIFeNCT06122259
Febrile Illness in Guinea
An observational study of Febrile Illness, run by Centre National de Formation et de Recherche en Sante Rurale at 1 site in Guinea.
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. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Febrile Illness
- How many people
- 2,500 participants
- Where
- 1 siteGuinea
- Study dates
- 27 Mar 2023to 31 Dec 2026
- How long will I take part?
- 21 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- History of hospitalization (for > 48 hours within the last 14 days) at any health facility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guinea1 site, 1 recruiting
- Recruiting
Centre National de Formation et de Recherche en Santé Rurale
Maférinya, Forécariah, 2649
Alsény Yarie Camara, MD, MPH, aycamara@maferinyah.org
Armand Saloun Kamano, MD, askamano@maferinyah.org
About this study
Official title: Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of symptoms and laboratory results at presentation and during follow-up
Proportion will be estimated
Measured: Day 0 and day 21
Syndromic and/or etiologic diagnoses as established at day 21
Proportion will be estimated
Measured: Day 0
Pattern and duration of antibiotic use (and other treatments)
Proportion and mean or median will be estimated
Measured: Day 0
Immediate or secondary hospital admissions and of secondary/unscheduled visits
Proportion will be estimated
Measured: Day 0 and day 21
Participants alive (with or without symptoms) or dead at day 21.
Survival or mortality rate will be estimated
Measured: 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
Mean or median level will be estimated
Measured: Day 0
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
Measured: Day 0
Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors
Proportions will be estimated
Measured: 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
Proportions will be estimated
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start27 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Febrile IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- Centre National de Formation et de Recherche en Sante Rurale
- Sponsor type
- Other government
- Collaborators
- Institute of Tropical Medicine, Belgium
- Responsible party
- Principal investigator, Karifa Kourouma, Centre National de Formation et de Recherche en Sante Rurale
- Investigators
- Emmanuel Bottieau, MD, MSc, PhD, Study director, Institute of Tropical Medicine, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122259
- Sponsor's protocol ID
- IRB/RR/AC/041_1616/22_ITM
- Other IDs
- 139/CNERS/23, IRB/RR/AC/041_1616/22
- Acronym
- MuSIFe
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is under development and will be filled when finalized.
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 26633014Roddy 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 31344116Carugati 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 30226134Alegana 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 30478314Maze 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 29454844Prasad 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 26126200Steketee 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 33891560Iroh 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 27059657Boillat-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 32896654D'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 24571753Wang 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 34173960Muianga 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 29733254Ushijima 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 33731022World 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)
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea
- ClinicalTrials.gov ID
- NCT06122259
- Acronym / sponsor ID
- MuSIFe / IRB/RR/AC/041_1616/22_ITM
- Conditions
- Febrile Illness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Centre National de Formation et de Recherche en Sante RuraleOther government
- Collaborators
- Institute of Tropical Medicine, Belgium
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Days
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- History of hospitalization (for > 48 hours within the last 14 days) at any health facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pattern of symptoms and laboratory results at presentation and during follow-up
Time frame: Day 0 and day 21
Proportion will be estimated
Syndromic and/or etiologic diagnoses as established at day 21
Time frame: Day 0
Proportion will be estimated
Pattern and duration of antibiotic use (and other treatments)
Time frame: Day 0
Proportion and mean or median will be estimated
Immediate or secondary hospital admissions and of secondary/unscheduled visits
Time frame: Day 0 and day 21
Proportion will be estimated
Participants alive (with or without symptoms) or dead at day 21.
Time frame: Day 21
Survival or mortality rate will be estimated
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- BackgroundWorld health organization. The WHO AWaRe (Access, Watch, Reserve) antibiotic book. WHO. 2022. https://www.who.int/publications/i/item/9789240062382. Accessed 11 Dec 2022
- Results publication: PubMed 26633014Crump 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.
- Results publication: PubMed 31344116Roddy 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.
- Results publication: PubMed 30226134Carugati 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.
- Results publication: PubMed 30478314Alegana 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.
- Results publication: PubMed 29454844Maze 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.
- Results publication: PubMed 26126200Prasad 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.
- Results publication: PubMed 33891560Steketee 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.
- Results publication: PubMed 27059657Iroh 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.
- Results publication: PubMed 32896654Boillat-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.
- Results publication: PubMed 24571753D'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.
- Results publication: PubMed 34173960Wang 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.
- Individual participant dataSharing planned: Yes. This is under development and will be filled when finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuel Bottieau, MD, MSc, PhD study director
Institute of Tropical Medicine, Antwerp, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Illness, run by Centre National de Formation et de Recherche en Sante Rurale at 1 site in Guinea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karifa Kourouma, MD, MSc (+224-628-765-320, KKourouma@maferinyah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of symptoms and laboratory results at presentation and during follow-up (time frame: Day 0 and day 21). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06122259, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.