Acute Febrile Illness
Conditions
Keywords
Acute Febrile Illness
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 and/or 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 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.
Interventions
None listed
Sponsors
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
National Institute of Allergy and Infectious Diseases (NIAID)
Ina-Respond
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Affected Organ System by Each Specific Pathogen | 3 years | The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen. |
| Number of Participants Enrolled Per Each Clinical Research Site | 3 years | 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. |
| Number of Vials Stored Based on Specimen Type | 3 years | Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study. |
Countries
Indonesia
Participant flow
Recruitment details
Recruitment period was done from July 2013 until October 2016
Pre-assignment details
From total target 1600 subjects only achieved 1492 subjects enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Hospitalized Participants With Acute Febrile Illness Hospitalized patients with any infectious disease with cardinal symptoms of acute fever (\<= 2 weeks). | 1,486 |
| Total | 1,486 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | Hospitalized Participants With Acute Febrile Illness |
|---|---|
| Age, Categorical <=18 years | 623 Participants |
| Age, Categorical >=65 years | 70 Participants |
| Age, Categorical Between 18 and 65 years | 793 Participants |
| Age, Continuous | 25.6 years STANDARD_DEVIATION 19.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1486 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1486 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Indonesia | 1486 Participants |
| Sex: Female, Male Female | 656 Participants |
| Sex: Female, Male Male | 830 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 89 / 1,486 |
| other Total, other adverse events | 8 / 1,486 |
| serious Total, serious adverse events | 0 / 1,486 |
Outcome results
Primary
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.
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.
Population: All participants who have specimens to be tested
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hospitalized Participants With Acute Febrile Illness | The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects. | Viruses | 621 Participants |
| Hospitalized Participants With Acute Febrile Illness | The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects. | Bacteria | 362 Participants |
| Hospitalized Participants With Acute Febrile Illness | The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects. | Parasites | 15 Participants |
| Hospitalized Participants With Acute Febrile Illness | The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects. | Multiple pathogens | 5 Participants |
| Hospitalized Participants With Acute Febrile Illness | The Etiologies (Bacteria, Viruses, Parasites, Fungi and Others) of Fever Illness Expressed in Percentages of Enrolled Subjects. | Unidentified pathogens | 483 Participants |
Secondary
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.
Time frame: 3 years
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hospitalized Participants With Acute Febrile Illness | Number of Participants Enrolled Per Each Clinical Research Site | RSUP dr Hasan Sadikin | 269 Participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants Enrolled Per Each Clinical Research Site | RSUP Sanglah | 213 Participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants Enrolled Per Each Clinical Research Site | RSUPN Dr Cipto Mangunkusumo | 65 Participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants Enrolled Per Each Clinical Research Site | RSPI Prof Dr Sulianti Saroso | 91 Participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants Enrolled Per Each Clinical Research Site | RSUP dr Wahidin Sudirohusodo | 201 Participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants Enrolled Per Each Clinical Research Site | RSUD dr Soetomo | 221 Participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants Enrolled Per Each Clinical Research Site | RSUP dr Sardjito | 169 Participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants Enrolled Per Each Clinical Research Site | RSUP dr Kariadi | 257 Participants |
Secondary
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.
Time frame: 3 years
Population: The organ system affected induced clinical symptoms that provide essential information for improving clinical management in differentiating between each identified pathogen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | Chikungunya | 1 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | Multiple pathogens | 0 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | Other single pathogen | 1 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | Dengue | 4 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | M. tuberculosis | 0 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | Rickettsia spp. | 0 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | Salmonella spp. | 1 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | E.Coli | 0 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | Influenza | 1 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | Leptospira spp. | 0 participants |
| Hospitalized Participants With Acute Febrile Illness | Number of Participants With Affected Organ System by Each Specific Pathogen | S. pneumoniae | 1 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | E.Coli | 1 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Influenza | 4 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | S. pneumoniae | 0 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | M. tuberculosis | 2 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Dengue | 7 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Other single pathogen | 2 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Salmonella spp. | 3 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Chikungunya | 1 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Rickettsia spp. | 0 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Leptospira spp. | 1 participants |
| Upper Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Multiple pathogens | 1 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Salmonella spp. | 1 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | E.Coli | 2 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Other single pathogen | 22 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Dengue | 0 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Rickettsia spp. | 1 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Multiple pathogens | 0 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Influenza | 10 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | M. tuberculosis | 5 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Leptospira spp. | 0 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | S. pneumoniae | 1 participants |
| Lower Respiratory | Number of Participants With Affected Organ System by Each Specific Pathogen | Chikungunya | 1 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | Rickettsia spp. | 3 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | E.Coli | 0 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | Leptospira spp. | 0 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | Other single pathogen | 7 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | Multiple pathogens | 1 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | S. pneumoniae | 0 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | Chikungunya | 1 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | M. tuberculosis | 0 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | Salmonella spp. | 0 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | Influenza | 0 participants |
| Skin and Soft Tissue | Number of Participants With Affected Organ System by Each Specific Pathogen | Dengue | 8 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | Multiple pathogens | 0 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | Dengue | 226 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | Salmonella spp. | 37 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | Rickettsia spp. | 48 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | Influenza | 4 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | Leptospira spp. | 19 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | Chikungunya | 10 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | E.Coli | 9 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | S. pneumoniae | 1 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | M. tuberculosis | 1 participants |
| Gastrointestinal | Number of Participants With Affected Organ System by Each Specific Pathogen | Other single pathogen | 23 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | Dengue | 1 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | Influenza | 0 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | Leptospira spp. | 0 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | M. tuberculosis | 0 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | Chikungunya | 0 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | E.Coli | 0 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | Other single pathogen | 0 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | Salmonella spp. | 0 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | Rickettsia spp. | 0 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | S. pneumoniae | 0 participants |
| Genitourinary | Number of Participants With Affected Organ System by Each Specific Pathogen | Multiple pathogens | 0 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | Salmonella spp. | 5 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | Multiple pathogens | 0 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | S. pneumoniae | 0 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | Dengue | 27 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | Chikungunya | 2 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | E.Coli | 0 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | Influenza | 0 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | Other single pathogen | 1 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | M. tuberculosis | 0 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | Leptospira spp. | 0 participants |
| Constitutional | Number of Participants With Affected Organ System by Each Specific Pathogen | Rickettsia spp. | 6 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | M. tuberculosis | 12 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | Leptospira spp. | 24 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | S. pneumoniae | 17 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | Influenza | 49 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | E.Coli | 9 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | Rickettsia spp. | 45 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | Salmonella spp. | 56 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | Multiple pathogens | 3 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | Dengue | 194 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | Chikungunya | 21 participants |
| Multiorgan | Number of Participants With Affected Organ System by Each Specific Pathogen | Other single pathogen | 59 participants |
Secondary
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.
Time frame: 3 years
Population: Each clinical research site and reference laboratory have been established to have capability to store repository specimen for future study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | Plasma EDTA | 7032 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | Buffy coat | 2311 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | Sputum | 29 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | Pleural fluid | 2 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | Feces | 27 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | Nasopharyngeal swab | 114 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | Urine | 205 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | Pus | 4 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | DNA | 2487 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | RNA | 1884 vials |
| Hospitalized Participants With Acute Febrile Illness | Number of Vials Stored Based on Specimen Type | LCS | 4 vials |