Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia

NCT04339179 | Completed Results

• 2 other identifiers: INA107U1111-1263-1317
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 19

Brief Summary

This observational study will investigate suspected infectious diseases of unknown etiology prospectively during outbreaks and at healthcare facilities, and retrospectively through historical samples where no etiology was ever determined. The study is designed to rapidly, flexibly, and consistently respond to any potential scenario in Indonesia, and the data collected will provide needed insight into the landscape of infectious diseases in the country. By better understanding the infectious causes of outbreaks and difficult hospitalized cases, the Indonesian Ministry of Health will be able to more accurately and efficiently control infectious diseases and craft healthcare policies.

Conditions

Infectious Disease

Keywords

Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Confirm Etiologies Among Suspected COVID-19 Cases

  Hospitalized suspected COVID-19 participants were monitored for at least 7-14 days after enrollment. Laboratory tests such as blood culture, RDT Influenza, RDT Dengue, Tubex TF, serology, and molecular were done to identify the etiology.

  at least 7-14 days after enrolment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult or child of any age, both men and women hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology or referral from the MoH as part of a suspected or identified outbreak of infectious disease from 19 active INA-RESPOND Network sites across Indonesia

You may qualify if:

• Adult or child of any age hospitalized with a current episode of illness with a presumed infectious disease of unidentified etiology
• Negative for Dengue virus infection by an antigen-based and antibody-based diagnostic test (i.e. NS1 antigen test and Dengue-specific IgM test)
• Negative for Salmonella Typhi infection by Standard of Care testing (i.e. blood culture, Widal test, or Tubex rapid test)
• Able to provide a documented informed consent
• Agrees to the collection and storage of specimens for laboratory testing and/or future research (participants may decline storage of specimens for future research)
• For Ongoing patients in outbreak situations: Referral from the MoH as part of a suspected or identified outbreak of infectious disease

You may not qualify if:

• Investigators' discretion for patient safety and well being

Sponsors & Collaborators

• Ina-Respond: lead

Study Sites (19)

Site 520: University of Udayana/Sanglah Hospital

Denpasar, Bali, 80114, Indonesia

Location

Site 560: University of Diponegoro/ Dr. Kariadi Hospital

Semarang, Central of Java, 50244, Indonesia

Location

Site 530: University of Indonesia/ Dr. Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Site 540: Penyakit Infeksi Sulianti Saroso Hospital

Jakarta, DKI Jakarta, 14340, Indonesia

Location

Site 590: Persahabatan Hospital

Jakarta, DKI Jakarta, 14340, Indonesia

Location

Site 660 RSUD Abdul Wahab Sjahranie

Samarinda, East Kalimantan, 75123, Indonesia

Location

Site 700 - RSUD Dr.TC Hillers

Maumere, East Nusa Tenggara, 86113, Indonesia

Location

Site 570: University of Airlangga/ Dr. Soetomo Hospital

Surabaya, East of Java, 60286, Indonesia

Location

Site 600 : Adam Malik Hospital

Medan, North Sumatra, 20136, Indonesia

Location

Site 650: Budi Kemuliaan Hospital

Batam, Riau Islands, Indonesia

Location

Site 630: M. Ansari Saleh Hospital

Banjarmasin, South Kalimantan, 70125, Indonesia

Location

Site 690 - RSUD Abepura

Jayapura, Special Region of Papua, 99351, Indonesia

Location

Site 510: University of Padjajaran/ Dr. Hasan Sadikin Hospital

Bandung, West Java, 40161, Indonesia

Location

Site 610 : RSU Kabupaten Tangerang

Tangerang, West Java, 15111, Indonesia

Location

Site 680 - RSUD dr Soedarso

Pontianak, West Kalimantan, 78111, Indonesia

Location

Site 670 - RSUD Dr. Zainoel Abidin

Banda Aceh, 24415, Indonesia

Location

Site 640: St. Carolus Hospital

Jakarta, 10440, Indonesia

Location

Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital

Makassar, 90245, Indonesia

Location

Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital

Yogyakarta, 55284, Indonesia

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, sputum, urine, stool, nasopharyngeal swab

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Publication Division
• Organization: INA-RESPOND

inapublikasi@ina-respond.net

+62214208693

Study Officials

• Dr. Muhammad Karyana, MPH

  National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 9, 2020
• Study Start: November 18, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 8, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-07

Locations

ID (19)