Trial Outcomes & Findings for The Etiology of Acute Febrile Illness Requiring Hospitalization (NCT NCT02763462)
NCT ID: NCT02763462
Last Updated: 2023-05-03
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
1492 participants
Primary outcome timeframe
Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.
Results posted on
2023-05-03
Participant Flow
Recruitment period was done from July 2013 until October 2016
From total target 1600 subjects only achieved 1492 subjects enrolled.
Participant milestones
| Measure |
Hospitalized Participants With Acute Febrile Illness.
Hospitalized patients with any infectious diseases with cardinal symptoms at acute fever (\<= 2 weeks)
|
|---|---|
|
Overall Study
STARTED
|
1492
|
|
Overall Study
COMPLETED
|
1486
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Hospitalized Participants With Acute Febrile Illness.
Hospitalized patients with any infectious diseases with cardinal symptoms at acute fever (\<= 2 weeks)
|
|---|---|
|
Overall Study
Protocol Violation
|
6
|
Baseline Characteristics
The Etiology of Acute Febrile Illness Requiring Hospitalization
Baseline characteristics by cohort
| Measure |
Hospitalized Participants With Acute Febrile Illness
n=1486 Participants
Hospitalized patients with any infectious disease with cardinal symptoms of acute fever (\<= 2 weeks).
|
|---|---|
|
Age, Categorical
<=18 years
|
623 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
793 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
70 Participants
n=5 Participants
|
|
Age, Continuous
|
25.6 years
STANDARD_DEVIATION 19.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
656 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
830 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1486 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1486 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Indonesia
|
1486 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Total length of time the subject will be in the study is 3 months after enrollment or until cured or maximum 1 year.Population: All participants who have specimens to be tested
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.
Outcome measures
| Measure |
Hospitalized Participants With Acute Febrile Illness
n=1486 Participants
Hospitalized patients with any infectious disease with cardinal symptoms of acute fever (\<=2 weeks)
|
Upper Respiratory
Organ system affected based on identified pathogens.
|
Lower Respiratory
Organ system affected based on identified pathogens.
|
Skin and Soft Tissue
Organ system affected based on identified pathogens.
|
Gastrointestinal
Organ system affected based on identified pathogens.
|
Genitourinary
Organ system affected based on identified pathogens.
|
Constitutional
Organ system affected based on identified pathogens.
|
Multiorgan
Organ system affected based on identified pathogens.
|
|---|---|---|---|---|---|---|---|---|
|
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
Viruses
|
621 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
Bacteria
|
362 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
Parasites
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
Multiple pathogens
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects.
Unidentified pathogens
|
483 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen.
The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen.
Outcome measures
| Measure |
Hospitalized Participants With Acute Febrile Illness
n=9 Participants
Hospitalized patients with any infectious disease with cardinal symptoms of acute fever (\<=2 weeks)
|
Upper Respiratory
n=22 Participants
Organ system affected based on identified pathogens.
|
Lower Respiratory
n=43 Participants
Organ system affected based on identified pathogens.
|
Skin and Soft Tissue
n=20 Participants
Organ system affected based on identified pathogens.
|
Gastrointestinal
n=378 Participants
Organ system affected based on identified pathogens.
|
Genitourinary
n=1 Participants
Organ system affected based on identified pathogens.
|
Constitutional
n=41 Participants
Organ system affected based on identified pathogens.
|
Multiorgan
n=489 Participants
Organ system affected based on identified pathogens.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
Dengue
|
4 participants
|
7 participants
|
0 participants
|
8 participants
|
226 participants
|
1 participants
|
27 participants
|
194 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
Salmonella spp.
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
37 participants
|
0 participants
|
5 participants
|
56 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
Rickettsia spp.
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
48 participants
|
0 participants
|
6 participants
|
45 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
Influenza
|
1 participants
|
4 participants
|
10 participants
|
0 participants
|
4 participants
|
0 participants
|
0 participants
|
49 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
Leptospira spp.
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
19 participants
|
0 participants
|
0 participants
|
24 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
Chikungunya
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
10 participants
|
0 participants
|
2 participants
|
21 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
E.Coli
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
9 participants
|
0 participants
|
0 participants
|
9 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
S. pneumoniae
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
17 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
M. tuberculosis
|
0 participants
|
2 participants
|
5 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
12 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
Multiple pathogens
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Affected Organ System by Each Specific Pathogen
Other single pathogen
|
1 participants
|
2 participants
|
22 participants
|
7 participants
|
23 participants
|
0 participants
|
1 participants
|
59 participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Hospitalized Participants With Acute Febrile Illness
n=1486 Participants
Hospitalized patients with any infectious disease with cardinal symptoms of acute fever (\<=2 weeks)
|
Upper Respiratory
Organ system affected based on identified pathogens.
|
Lower Respiratory
Organ system affected based on identified pathogens.
|
Skin and Soft Tissue
Organ system affected based on identified pathogens.
|
Gastrointestinal
Organ system affected based on identified pathogens.
|
Genitourinary
Organ system affected based on identified pathogens.
|
Constitutional
Organ system affected based on identified pathogens.
|
Multiorgan
Organ system affected based on identified pathogens.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Enrolled Per Each Clinical Research Site
RSUP dr Hasan Sadikin
|
269 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Enrolled Per Each Clinical Research Site
RSUP Sanglah
|
213 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Enrolled Per Each Clinical Research Site
RSUPN Dr Cipto Mangunkusumo
|
65 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Enrolled Per Each Clinical Research Site
RSPI Prof Dr Sulianti Saroso
|
91 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Enrolled Per Each Clinical Research Site
RSUP dr Wahidin Sudirohusodo
|
201 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Enrolled Per Each Clinical Research Site
RSUP dr Kariadi
|
257 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Enrolled Per Each Clinical Research Site
RSUD dr Soetomo
|
221 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Enrolled Per Each Clinical Research Site
RSUP dr Sardjito
|
169 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study.
Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study.
Outcome measures
| Measure |
Hospitalized Participants With Acute Febrile Illness
n=14099 vials
Hospitalized patients with any infectious disease with cardinal symptoms of acute fever (\<=2 weeks)
|
Upper Respiratory
Organ system affected based on identified pathogens.
|
Lower Respiratory
Organ system affected based on identified pathogens.
|
Skin and Soft Tissue
Organ system affected based on identified pathogens.
|
Gastrointestinal
Organ system affected based on identified pathogens.
|
Genitourinary
Organ system affected based on identified pathogens.
|
Constitutional
Organ system affected based on identified pathogens.
|
Multiorgan
Organ system affected based on identified pathogens.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Vials Stored Based on Specimen Type
Plasma EDTA
|
7032 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
Buffy coat
|
2311 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
Sputum
|
29 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
Pleural fluid
|
2 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
Feces
|
27 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
Nasopharyngeal swab
|
114 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
Urine
|
205 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
LCS
|
4 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
Pus
|
4 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
DNA
|
2487 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Vials Stored Based on Specimen Type
RNA
|
1884 vials
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Hospitalized Participants With Acute Febrile Illness
Serious events: 0 serious events
Other events: 8 other events
Deaths: 89 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hospitalized Participants With Acute Febrile Illness
n=1486 participants at risk
Hospitalized patients with any infectious disease with cardinal symptoms of acute fever (\<=2 weeks)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.40%
6/1486 • Number of events 7 • 48 hours after study related blood drawn
Any untoward or unfavorable medical occurrence in a human subject that occurs within 48 hours of a study-related blood draw that is possibly, probably, or definitely related to the blood draw. Any event outside of this 48 hour window period will not be considered an AE for this study.
|
|
General disorders
Fever
|
0.07%
1/1486 • Number of events 1 • 48 hours after study related blood drawn
Any untoward or unfavorable medical occurrence in a human subject that occurs within 48 hours of a study-related blood draw that is possibly, probably, or definitely related to the blood draw. Any event outside of this 48 hour window period will not be considered an AE for this study.
|
|
Nervous system disorders
Convulsion
|
0.07%
1/1486 • Number of events 1 • 48 hours after study related blood drawn
Any untoward or unfavorable medical occurrence in a human subject that occurs within 48 hours of a study-related blood draw that is possibly, probably, or definitely related to the blood draw. Any event outside of this 48 hour window period will not be considered an AE for this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place