Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02763462
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2016-04-04
Brief Title:
The Etiology of Acute Febrile Illness Requiring Hospitalization
Sponsor:
Ina-Respond
Organization:
Ina-Respond
Study Overview
Official Title:
The Etiology of Acute Febrile Illness Requiring Hospitalization AFIRE A Multicenter Study of the Indonesia Research Partnership on Infectious Disease INA-RESPOND
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFIRE
Brief 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 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
1 To provide clinical data that are essential for improving andor developing clinical management and health policies
2 To enhance research capacity and networking for infectious diseases in Indonesia by improving clinical research site capability in conducting research relevant to public health
3 To establish a repository of biological specimens for future study such as determining the etiology of undiagnosed fever andor 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 andor 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
Primary Objective
To identify the etiology of acute febrile illness cases and evaluate clinical manifestations and outcomes
Secondary Objectives
1 To provide clinical data that are essential for improving andor developing clinical management and health policies
2 To enhance research capacity and networking for infectious diseases in Indonesia by improving clinical research site capability in conducting research relevant to public health
3 To establish a repository of biological specimens for future study such as determining the etiology of undiagnosed fever andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1263-2248 | OTHER | None | None |
| HHSN261200800001E | OTHER | None | None |
| HHSN261201500003I | OTHER | NIAID | None |