Acute Febrile IllnessAFIRENCT02763462
The Etiology of Acute Febrile Illness Requiring Hospitalization
An observational study of Acute Febrile Illness, run by Ina-Respond at 8 sites in Indonesia.
Trial summary
This study is an observational cohort study of hospitalized patients with fever. This study will collect demographic data, history of illness, signs and symptoms, results of laboratory tests, clinical course, treatment and outcome. This study conducted at eight INA-RESPOND hospitals. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Acute Febrile Illness
- How many people
- 1,492 participants
- Where
- 8 sitesIndonesia
- Study dates
- Jul 2013to Aug 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitalized patients with acute febrile illness.
Who may be able to join
- Age ≥1 year
- Acute febrile illness requiring hospitalization (fever defined as temperature recorded ≥38.0°C during the first 24 hour period of hospitalization).
- Hospitalized within the past 24 hours.
- Willing to allow storage of blood and other specimens for use in future studies of infectious diseases.
Who cannot join
- Hospitalized within the past 3 months, not including current hospitalization for acute febrile illness.
- Inpatient transfer from another hospital.
- A known medical disorder or other circumstance, which in the opinion of the PI might make the participation of the individual unsafe or difficult.
- Examples include, but not limited to: mental illness which could affect compliance with protocol, an anemic patient preventing blood draw.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Indonesia8 sites
University of Padjajaran/ Dr. Hasan Sadikin Hospital
Bandung, West Java, 40161
University of Udayana/Sanglah Hospital
Denpasar, Bali, 80114
University of Indonesia/ Dr. Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, 10430
Penyakit Infeksi Sulianti Saroso Hospital
Jakarta, DKI Jakarta, 14340
University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
Makassar, 90245
University of Diponegoro/ Dr. Kariadi Hospital
Semarang, Central Java, 50244
University of Airlangga/ Dr. Soetomo Hospital
Surabaya, East Java, 60286
University of Gadjah Mada/ Dr. Sardjito Hospital
Yogyakarta, 55284
About this study
Official title: The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE). A Multicenter Study of the Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
This study is an observational cohort study of hospitalized patients with fever. This study will collect demographic data, history of illness, signs and symptoms, results of laboratory tests, clinical course, treatment and outcome. This study conducted at eight INA-RESPOND hospitals. Potential study patients will be any patients (both children and adults).
Read the detailed description
This study is an observational cohort to identify the etiologies of acute febrile illness (less than or equal to 2 weeks), which are thought to be endemic or novel in a certain area. Therefore, there are no hypotheses that require sample size calculation to be tested. It is expected that this study will enroll a minimum of 200 patients per site: approximately 100 adults and 100 pediatric cases. The final sample size is therefore estimated to be 1600.
Primary Objective:
To identify the etiology of acute febrile illness cases and evaluate clinical manifestations and outcomes.
Secondary Objectives:
- To provide clinical data that are essential for improving and/or developing clinical management and health policies.
- To enhance research capacity and networking for infectious diseases in Indonesia by improving clinical research site capability in conducting research relevant to public health.
- To establish a repository of biological specimens for future study, such as determining the etiology of undiagnosed fever and/or its pathogenicity and its public health importance.
This study will be conducted at all the INA-RESPOND hospitals (8 hospitals):
- Dr. Cipto Mangunkusumo Hospital , Jakarta
- Penyakit Infeksi Prof. Dr. Sulianti Saroso Hospital, Jakarta
- Dr. Hasan Sadikin Hospital, Bandung
- Dr. Kariadi Hospital, Semarang
- Dr. Sardjito Hospital, Yogyakarta
- Dr. Soetomo Hospital, Surabaya
- Sanglah Hospital, Bali
- Dr. Wahidin Soedirohusodo Hospital, Makassar
The study will enroll eligible fever patients for a period of up to 1 year. Follow-up may be up until one year after last subject is enrolled. Stored samples will be investigated during the study and/or after study completion.
After enrollment, patients will be seen at 14-28 days and at 3 months post enrollment. Patients will be seen every 3 months (6, 9, and 12 months within a window period of +/- 14 days) until cured and no related symptoms persists or the one year time point is reached. The samples will be collected for storage at enrollment, the 14-28 day visit, at 3 months and every 3 months thereafter if not cured.
- Conditions
- Acute Febrile Illness
- Keywords
- Acute Febrile Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
Any pathogens identified as a caused of febrile illness based on laboratory tests such as blood culture, other culture (sputum/ pus/ urine/ feces), serology, and molecular.
Measured: Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.
Secondary outcomes (3)
Number of Participants With Affected Organ System by Each Specific Pathogen
The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen.
Measured: 3 years
Number of Participants Enrolled Per Each Clinical Research Site
Eight clinical research sites in 7 cities in Indonesia have been established to conduct clinical research that improved research capacity and networking for Infectious diseases in Indonesia.
Measured: 3 years
Number of Vials Stored Based on Specimen Type
Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJul 2013
- Primary completionOct 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ina-Respond
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Prof. dr. M. Hussein Gasem, PhD, SpPD-KPTI, Principal investigator, University of Diponegoro/ Dr. Kariadi hospitalProf. Emiliana Tjitra, MSC, Ph.D, Principal investigator, NIHRD, IndonesiaDr. Bachti Alisjahbana, PhD, SpPD-KPTI, Principal investigator, Univerversity of Padjajaran / Dr. Hasan Sadikin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763462
- Sponsor's protocol ID
- INA101
- Other IDs
- U1111-1263-2248, HHSN261200800001E, HHSN261201500003I
- Acronym
- AFIRE
- Status last verified
- May 2023
- First submitted
- 4 Apr 2016
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE). A Multicenter Study of the Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
- ClinicalTrials.gov ID
- NCT02763462
- Acronym / sponsor ID
- AFIRE / INA101
- Conditions
- Acute Febrile Illness
- Keywords
- Acute Febrile Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,492 participants (actual)
- Lead sponsor
- Ina-RespondUniversity, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2013 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 27 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an observational cohort study of hospitalized patients with fever. This study will collect demographic data, history of illness, signs and symptoms, results of laboratory tests, clinical course, treatment and outcome. This study conducted at eight INA-RESPOND hospitals. Potential study patients will be any patients (both children and adults).
Detailed description
This study is an observational cohort to identify the etiologies of acute febrile illness (less than or equal to 2 weeks), which are thought to be endemic or novel in a certain area. Therefore, there are no hypotheses that require sample size calculation to be tested. It is expected that this study will enroll a minimum of 200 patients per site: approximately 100 adults and 100 pediatric cases. The final sample size is therefore estimated to be 1600.
Primary Objective:
To identify the etiology of acute febrile illness cases and evaluate clinical manifestations and outcomes.
Secondary Objectives:
- To provide clinical data that are essential for improving and/or developing clinical management and health policies.
- To enhance research capacity and networking for infectious diseases in Indonesia by improving clinical research site capability in conducting research relevant to public health.
- To establish a repository of biological specimens for future study, such as determining the etiology of undiagnosed fever and/or its pathogenicity and its public health importance.
This study will be conducted at all the INA-RESPOND hospitals (8 hospitals):
- Dr. Cipto Mangunkusumo Hospital , Jakarta
- Penyakit Infeksi Prof. Dr. Sulianti Saroso Hospital, Jakarta
- Dr. Hasan Sadikin Hospital, Bandung
- Dr. Kariadi Hospital, Semarang
- Dr. Sardjito Hospital, Yogyakarta
- Dr. Soetomo Hospital, Surabaya
- Sanglah Hospital, Bali
- Dr. Wahidin Soedirohusodo Hospital, Makassar
The study will enroll eligible fever patients for a period of up to 1 year. Follow-up may be up until one year after last subject is enrolled. Stored samples will be investigated during the study and/or after study completion.
After enrollment, patients will be seen at 14-28 days and at 3 months post enrollment. Patients will be seen every 3 months (6, 9, and 12 months within a window period of +/- 14 days) until cured and no related symptoms persists or the one year time point is reached. The samples will be collected for storage at enrollment, the 14-28 day visit, at 3 months and every 3 months thereafter if not cured.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitalized patients with acute febrile illness.
Key inclusion criteria (4 listed)
- Age ≥1 year
- Acute febrile illness requiring hospitalization (fever defined as temperature recorded ≥38.0°C during the first 24 hour period of hospitalization).
- Hospitalized within the past 24 hours.
- Willing to allow storage of blood and other specimens for use in future studies of infectious diseases.
Key exclusion criteria (4 listed)
- Hospitalized within the past 3 months, not including current hospitalization for acute febrile illness.
- Inpatient transfer from another hospital.
- A known medical disorder or other circumstance, which in the opinion of the PI might make the participation of the individual unsafe or difficult.
- Examples include, but not limited to: mental illness which could affect compliance with protocol, an anemic patient preventing blood draw.
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
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
Time frame: Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.
Any pathogens identified as a caused of febrile illness based on laboratory tests such as blood culture, other culture (sputum/ pus/ urine/ feces), serology, and molecular.
3 secondary outcomes
Number of Participants With Affected Organ System by Each Specific Pathogen
Time frame: 3 years
Number of Participants Enrolled Per Each Clinical Research Site
Time frame: 3 years
Number of Vials Stored Based on Specimen Type
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share data
Related trials for Acute Febrile Illness
RecruitingObservational study
Febrile Infants Swedish Study
Febrile Illness Acute, Meningitis, Bacterial
RecruitingPhase 4
Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults
Acute Febrile Illness, Pneumococcal Infections
RecruitingObservational study
Clinical Aspects, Management and Surveillance of Febrile Illnesses in DRC
Febrile Illness Acute, Biomarkers
RecruitingObservational study
Causes and Outcomes of Febrile Illness in Health Facilities in Rural South and Southeast Asia
Acute Febrile Illness
RecruitingObservational study
The Fever Clinic Acute Respiratory Cohort
Acute Respiratory Infections, Febrile Illnesses
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. This study is not recruiting at the moment.
Prof. dr. M. Hussein Gasem, PhD, SpPD-KPTI principal investigator
University of Diponegoro/ Dr. Kariadi hospital
Prof. Emiliana Tjitra, MSC, Ph.D principal investigator
NIHRD, Indonesia
Dr. Bachti Alisjahbana, PhD, SpPD-KPTI principal investigator
Univerversity of Padjajaran / Dr. Hasan Sadikin Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Febrile Illness, run by Ina-Respond at 8 sites in Indonesia.
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 4 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: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Indonesia. 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?
Yes. Results are posted in the registry (first posted 27 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects. (time frame: Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2023.