## Protocol Section
### Identification Module
**NCT ID:** NCT04339179

**Acronym:** INA-ORCHID

**Brief Title:** Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia

**Official Title:** INA-RESPOND Observational Research on Infectious Disease Outbreaks and Difficult Cases of Unidentified Etiology in Indonesia

#### Organization Study ID Info
**ID:** INA107
#### Organization
**Class:** OTHER
**Full Name:** Ina-Respond
#### Secondary ID Infos
**Domain:** WHO UTN Number
**ID:** U1111-1263-1317
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-24

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-11-18

**Type:** ACTUAL

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2020-04-09
**Type:** ACTUAL
**Study First Submit Date:** 2020-04-06
**Study First Submit QC Date:** 2020-04-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ina-Respond

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** This is a study to identify the causative agents and describe the clinical characteristics of infectious disease outbreaks and difficult cases of unidentified etiology in Indonesia. It is a retrospective and prospective observational study with an exploratory design. There will be no intervention to the participants that is intended to affect their SoC or clinical outcome.

Retrospective study activities will be ongoing throughout the duration of the study. The INA-RESPOND Reference Lab will perform research tests on various specimens collected as part of historical outbreaks and previous difficult cases where an etiology was never identified.

Prospective study activities will be initiated upon official request from health authorities and health facilities/institutions. Requests are expected to be filtered through and evaluated by the 19 active INA-RESPOND Network sites before inclusion in the study. Samples collected during outbreaks and from difficult cases of unknown etiology will be analyzed at the INA-RESPOND Reference Lab at their own pace. Results from any research tests will be shared with the requesting authorities as research-use-only and are not intended to alter standard of care.

### Conditions Module

**Conditions:**

- Infectious Disease

**Keywords:**

- Infectious Disease

### Design Module

#### Bio Spec

**Description:** whole blood, sputum, urine, stool, nasopharyngeal swab

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2500

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by Reference Laboratory tests expressed in percentages of enrolled subjects.

**Measure:** To identify the causative agents and describe the clinical characteristics of presumptive infections reported during infectious diseases outbreaks or referred from difficult cases of unidentified etiology in Indonesia.

**Time Frame:** [Time Frame: 5 years] [No Safety Issue]

#### Secondary Outcomes

**Description:** Signs, symptoms, and clinical laboratory data from each confirmed diagnosis calculated in percentages.

**Measure:** To describe the disease course and case management of the presumptive infections

**Time Frame:** [Time Frame: 5 years] [No Safety Issue]

**Description:** The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by both point-of-care diagnostic tests and Reference Laboratory tests expressed as ratios.

**Measure:** To assess the accuracy of diagnostic tests of the presumptive infections

**Time Frame:** [Time Frame: 5 years] [No Safety Issue]

**Description:** Enrolled subject condition at end of study and duration of illness from enrollment to end of study.

**Measure:** To assess treatments and short-term outcomes of the presumptive infections

**Time Frame:** [Time Frame: 5 years] [No Safety Issue]

**Description:** The etiologies (bacteria, viruses, parasites, fungi and others) of illness determined by Reference Laboratory tests expressed in percentages of enrolled subjects.

**Measure:** To generate epidemiologic data to inform ongoing and future disease control and prevention efforts

**Time Frame:** [Time Frame: 5 years] [No Safety Issue]

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

* Investigators' discretion for patient safety and well being

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** m.karyana@ina-respond.net

**Name:** Dr. Muhammad Karyana, MPH

**Phone:** +62 21 42879189

**Role:** CONTACT

**Contact 2:**

**Email:** arlindona@ina-respond.net

**Name:** dr. Dona Arlinda, M.Sc.

**Phone:** +62 21 42879189

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Denpasar

**Contacts:**

***Contact 1:***

- **Email:** tutiparwati@yahoo.com

- **Name:** Prof. Dr. Ketut Tuti Merati, SpPD-KPTI

- **Phone:** +62361246274

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr. dr. Agus Somya Sp.PD (KPTI)

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 520: University of Udayana/Sanglah Hospital

**State:** Bali

**Status:** NOT_YET_RECRUITING

**Zip:** 80114

**Location 2:**

**City:** Semarang

**Contacts:**

***Contact 1:***

- **Email:** mhgasem@yahoo.com

- **Name:** Prof. dr. Muhammad Hussein Gasem, PhD, SpPD-KPTI

- **Phone:** +62248446757

- **Role:** CONTACT

***Contact 2:***

- **Name:** dr. Nur Farhanah Sp.PD, K-PTI, MSi.Med

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 560: University of Diponegoro/ Dr. Kariadi Hospital

**State:** Central Of Java

**Status:** NOT_YET_RECRUITING

**Zip:** 50244

**Location 3:**

**City:** Jakarta

**Contacts:**

***Contact 1:***

- **Email:** psdrmn@yahoo.com

- **Name:** Prof. Dr. Pratiwi Sudarmono, PhD, SpMK (K)

- **Phone:** +62 21 315 59 96

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr. dr. Evy Yunihastuti, Sp.PD-KAI

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

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

**State:** DKI Jakarta

**Status:** NOT_YET_RECRUITING

**Zip:** 10430

**Location 4:**

**City:** Jakarta

**Contacts:**

***Contact 1:***

- **Email:** viandrashakti@yahoo.co.id

- **Name:** Dr. Vivi Lisdawati, Msi,Apt

- **Phone:** +62216506559

- **Phone Ext:** 3119

- **Role:** CONTACT

***Contact 2:***

- **Name:** dr. Adria Rusli, Sp.P

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 540: Penyakit Infeksi Sulianti Saroso Hospital

**State:** DKI Jakarta

**Status:** NOT_YET_RECRUITING

**Zip:** 14340

**Location 5:**

**City:** Jakarta

**Contacts:**

***Contact 1:***

- **Email:** erlina_burhan@yahoo.com

- **Name:** Dr. dr. Erlina Burhan, SpP(K), MSc

- **Phone:** +628161628471

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr. dr. Erlina Burhan, SpP(K), MSc

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 590: Persahabatan Hospital

**State:** DKI Jakarta

**Status:** NOT_YET_RECRUITING

**Zip:** 14340

**Location 6:**

**City:** Samarinda

**Contacts:**

***Contact 1:***

- **Email:** carta_g@yahoo.com

- **Name:** Dr. dr. Carta Agrawanto Gunawan, Sp.PD, K-PTI

- **Phone:** +62 541738118

- **Role:** CONTACT

***Contact 2:***

- **Email:** sunarto.ang1967@gmail.com

- **Name:** Dr. dr. Sunarto Ang, M.Sc

- **Phone:** +62 541738118

- **Role:** CONTACT

**Country:** Indonesia

**Facility:** Site 660 RSUD Abdul Wahab Sjahranie

**State:** East Kalimantan

**Status:** NOT_YET_RECRUITING

**Zip:** 75123

**Location 7:**

**City:** Maumere

**Contacts:**

***Contact 1:***

- **Email:** asepforever@yahoo.com

- **Name:** dr. Asep Purnama, Sp.PD

- **Phone:** (0382) 2426133

- **Role:** CONTACT

***Contact 2:***

- **Name:** dr. Asep Purnama, Sp.PD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 700 - RSUD Dr.TC Hillers

**State:** East Nusa Tenggara

**Status:** NOT_YET_RECRUITING

**Zip:** 86113

**Location 8:**

**City:** Surabaya

**Contacts:**

***Contact 1:***

- **Email:** divtropin@yahoo.com

- **Name:** Prof. Dr.Usman Hadi SpPD-KPTI

- **Phone:** +631 5035975

- **Role:** CONTACT

***Contact 2:***

- **Name:** Prof. Dr.Usman Hadi SpPD, KPT

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 570: University of Airlangga/ Dr. Soetomo Hospital

**State:** East Of Java

**Status:** NOT_YET_RECRUITING

**Zip:** 60286

**Location 9:**

**City:** Medan

**Contacts:**

***Contact 1:***

- **Email:** prabowob14@yahoo.com

- **Name:** dr. Bambang Prabowo, MARS

- **Phone:** (+6261) 8360143

- **Role:** CONTACT

***Contact 2:***

- **Name:** dr. Tambar Kembaren SpPD, K-PTI

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 600 : Adam Malik Hospital

**State:** North Sumatra

**Status:** NOT_YET_RECRUITING

**Zip:** 20136

**Location 10:**

**City:** Jayapura

**Contacts:**

***Contact 1:***

- **Email:** darmajaimadegede@yahoo.co.id

- **Name:** Dr I Made Gede Darmaja, SpPD FINASIM

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr I Made Gede Darmaja, SpPD FINASIM

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 690 - RSUD Abepura

**State:** Papua

**Status:** NOT_YET_RECRUITING

**Zip:** 99351

**Location 11:**

**City:** Batam

**Contacts:**

***Contact 1:***

- **Email:** bratasena.s@gmail.com

- **Name:** Dr. Bratasena, Sp.PD, M.Ked

- **Phone:** (0778) 454044

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr. Bratasena, Sp.PD, M.Ked

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 650: Budi Kemuliaan Hospital

**State:** Riau Islands

**Status:** NOT_YET_RECRUITING

**Location 12:**

**City:** Banjarmasin

**Contacts:**

***Contact 1:***

- **Name:** dr. Anna Martiana Afida, Sp.PK,MPH

- **Phone:** +62 511 6710000

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr. Hj. Wiwit Agung SNC, SPPD.K-Ger

- **Phone:** +62 511 6710000

- **Role:** CONTACT

***Contact 3:***

- **Name:** Dr. Hj. Wiwit Agung SNC, SPPD.K-Ger

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 630: M. Ansari Saleh Hospital

**State:** South Kalimantan

**Status:** NOT_YET_RECRUITING

**Zip:** 70125

**Location 13:**

**City:** Bandung

**Contacts:**

***Contact 1:***

- **Email:** b.alisjahbana@gmail.com

- **Name:** dr. Bachti Alisjahbana, PhD, SpPD-KPTI

- **Phone:** +62222030776

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr. Rudi Wisaksana Sp.PD-KPTI.,Ph.D

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

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

**State:** West Java

**Status:** NOT_YET_RECRUITING

**Zip:** 40161

**Location 14:**

**City:** Tangerang

**Contacts:**

***Contact 1:***

- **Email:** lokidadewi@yahoo.com

- **Name:** dr. Dewi Lokida, SpPK

- **Phone:** +62215523507

- **Role:** CONTACT

***Contact 2:***

- **Name:** dr. I Gede Rai Kosa, SpPD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** dr. Arif Budiman, SpA

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** dr. Chakrawati Hayuningsih, SpPK

- **Role:** SUB_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 610 : RSU Kabupaten Tangerang

**State:** West Java

**Status:** RECRUITING

**Zip:** 15111

**Location 15:**

**City:** Pontianak

**Contacts:**

***Contact 1:***

- **Email:** yastu15c@yahoo.com

- **Name:** dr. Ivan Lumban Toruan, Sp.PD

- **Phone:** (0561)737701

- **Role:** CONTACT

***Contact 2:***

- **Name:** dr. Ivan Lumban Toruan, Sp.PD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 680 - RSUD dr Soedarso

**State:** West Kalimantan

**Status:** NOT_YET_RECRUITING

**Zip:** 78111

**Location 16:**

**City:** Banda Aceh

**Contacts:**

***Contact 1:***

- **Email:** kurnia_jamil@unsyiah.ac.id

- **Name:** Dr. dr. Kurnia Fitri Jamil, M.Kes., Sp.PD-KPTI

- **Phone:** (0651) 22616

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr. dr. Kurnia Fitri Jamil, M.Kes., Sp.PD-KPTI

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 670 - RSUD Dr. Zainoel Abidin

**Status:** NOT_YET_RECRUITING

**Zip:** 24415

**Location 17:**

**City:** Jakarta

**Contacts:**

***Contact 1:***

- **Email:** emil.tjitra@gmail.com

- **Name:** Prof. dr. Emiliana Tjitra, Msc, PhD

- **Phone:** (021) 3904441

- **Role:** CONTACT

***Contact 2:***

- **Name:** dr. Emon Winardi Danudirgo, SpPD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

**Facility:** Site 640: St. Carolus Hospital

**Status:** NOT_YET_RECRUITING

**Zip:** 10440

**Location 18:**

**City:** Makassar

**Contacts:**

***Contact 1:***

- **Email:** mansyur_arief@yahoo.com

- **Name:** Prof. Dr. Mansyur Arif, PhD, SpPK (K)

- **Phone:** +6411-582678

- **Role:** CONTACT

***Contact 2:***

- **Name:** dr. Sudirman Katu SpPD, K-PTI

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

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

**Status:** NOT_YET_RECRUITING

**Zip:** 90245

**Location 19:**

**City:** Yogyakarta

**Contacts:**

***Contact 1:***

- **Email:** abutholibaman@ugm.ac.id

- **Name:** dr. Abu Tholib Aman, MSc, PhD, SpMK(K)

- **Phone:** +6274560300

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dr. Yanri Subronto PhD, Sp.PD, FINASIM

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Indonesia

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

**Status:** NOT_YET_RECRUITING

**Zip:** 55284

#### Overall Officials

**Official 1:**

**Affiliation:** National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

**Name:** Dr. Muhammad Karyana, MPH

**Role:** PRINCIPAL_INVESTIGATOR

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2023-02-26

- Date Unknown: Unknown

#### Event: RESET

- Date: 2023-12-06

- Date Unknown: Unknown

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infectious Disease

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infectious Disease

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2023-02-26

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2023-02-26

- Reset Date: 2023-12-06

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- MCP Release N: Unknown

- Release Date: 2023-12-21

- Reset Date: Unknown

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
