NCT02763462

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,492

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

February 27, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

3.3 years

First QC Date

April 4, 2016

Results QC Date

September 1, 2022

Last Update Submit

May 1, 2023

Conditions

Acute Febrile Illness

Keywords

Acute Febrile Illness

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    3 years

  • Number of Participants Enrolled Per Each Clinical Research Site

    3 years

  • Number of Vials Stored Based on Specimen Type

    3 years

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients with acute febrile illness.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Udayana/Sanglah Hospital

Denpasar, Bali, 80114, Indonesia

Location

University of Diponegoro/ Dr. Kariadi Hospital

Semarang, Central Java, 50244, Indonesia

Location

University of Indonesia/ Dr. Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Penyakit Infeksi Sulianti Saroso Hospital

Jakarta, DKI Jakarta, 14340, Indonesia

Location

University of Airlangga/ Dr. Soetomo Hospital

Surabaya, East Java, 60286, Indonesia

Location

University of Padjajaran/ Dr. Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

Location

University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital

Makassar, 90245, Indonesia

Location

University of Gadjah Mada/ Dr. Sardjito Hospital

Yogyakarta, 55284, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, buffy coat, urine, throat swab, nasal swab.

Results Point of Contact

Title
Publication Division
Organization
INA-RESPOND
inapublikasi@ina-respond.net
+62214208693

Study Officials

  • Prof. dr. M. Hussein Gasem, PhD, SpPD-KPTI

    University of Diponegoro/ Dr. Kariadi hospital

    PRINCIPAL INVESTIGATOR

  • Prof. Emiliana Tjitra, MSC, Ph.D

    NIHRD, Indonesia

    PRINCIPAL INVESTIGATOR

  • Dr. Bachti Alisjahbana, PhD, SpPD-KPTI

    Univerversity of Padjajaran / Dr. Hasan Sadikin Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

May 5, 2016

Study Start

July 1, 2013

Primary Completion

October 1, 2016

Study Completion

August 1, 2017

Last Updated

May 3, 2023

Results First Posted

February 27, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

No plan to share data

Locations

ID(8)