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RecruitingNCT07929519Updated Nov 10, 2026

Clinical Characteristics, Treatment, Diagnostic Findings, and Outcomes of Tuberculous Meningitis in Indonesia, 2022-2025

An observational study in Tuberculous Meningitis, sponsored by Ina-Respond. Recruiting at 6 sites in Indonesia. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Ina-Respond · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 10, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Sex
All
01

Study summary

TBM Study is a multicenter, observational, retrospective cohort study of Tuberculous Meningitis (TBM) patients who underwent treatment at the hospital during the 2022-2025 period. The goal of this study is to learn about the clinical characteristics, diagnostic findings, drug resistance profiles, treatment regimens, complications, and treatment outcomes of patients diagnosed with TBM who were admitted to the study hospitals between 2022 and 2025. This study uses retrospective data obtained from electronic medical records (EMR).

Read the detailed description

Participants who admitted to the participating hospital sites between January 1, 2022, and December 31, 2025, have a discharge diagnosis of TBM (ICD-10 code A17.0) or documented TBM diagnosis in the hospital EMR system, and have accessible data available in the EMR will be enrolled to this study. The data will be collected at five timepoints:

Timepoint 1: Hospital Admission Timepoint 2: TB Treatment Initiation Timepoint 3: Hospital Discharge Timepoint 4: End of Intensive Phase Timepoint 5: End of Treatment

Six hospitals participate as the study sites. They are:

  1. RS Penyakit Infeksi Prof. Dr. Sulianti Saroso (RSPI SS), Jakarta
  2. RS Pusat Otak Nasional Prof. Dr. dr. Mahar Mardjono (RSPON), Jakarta
  3. RSUP dr Mohammad Hoesin, Palembang
  4. RSUP dr M Djamil, Padang
  5. RSUP Prof Dr I.G.N.G. Ngoerah, Denpasar
  6. RSUP dr Johannes Leimena, Maluku

No biological specimens will be collected as part of the study. Data will be extracted from electronic medical records (EMR) at the study participating hospitals. Patient data will be collected from existing records at predefined time points through the end of treatment.

02

Conditions studied

  • Tuberculous Meningitis
03

In context

Tuberculosis, Meningeal

31 studies on the registry are indexed under Tuberculosis, Meningeal; 9 are open to participants now.

Browse Tuberculosis, Meningeal studies →

Lead sponsor

Ina-Respond is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The population of this study consists of patients diagnosed with TBM who were admitted to participating hospital sites. Eligible cases will be identified through hospital EMR systems using the ICD-10 code A17.0 or based on a documented diagnosis of TBM in the EMR and will be verified by clinical documentation.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Admited to the participating hospital sites between January 1, 2022, and December 31, 2025
  • Have a discharge diagnosis of TBM (ICD-10 code A17.0) or documented TBM diagnosis in the hospital EMR system.
  • Have accessible data available in the EMR.

Exclusion criteria

Exclusion Criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • OtherNo intervention (observational study)

    No intervention (observational study)

06

What researchers measure

Primary outcomes

  1. The proportion of TBM cases across TBM categories of clinical characteristics, diagnostic findings, drug resistance profiles, treatment regimens, complications, and treatment outcomes according to the Marais consensus diagnostic criteria

    Time frame: During TB treatment, an average 8-12 months

Secondary outcomes

  1. To estimate the annual trend of TBM admissions at the hospitals from 2022 to 2025

    Time frame: at hospital admission timepoint

  2. The proportion of TBM cases across comorbidities, concurrent pulmonary or extrapulmonary tuberculosis, and co-infections according to the Marais consensus diagnostic criteria

    Time frame: During hospitalization, an average 2 weeks

  3. The proportion of TBM cases across use and diagnostic yield of laboratory investigations and neuroimaging modalities according to the Marais consensus diagnostic criteria

    Time frame: During TB treatment, an average 8-12 months

  4. The proportion of TBM cases across factors associated with in-hospital mortality, end-of treatment outcome, and neurological sequelae according to the Marais consensus diagnostic criteria

    Time frame: During TB treatment, an average 8-12 months

  5. The proportion of TBM cases across post-discharge follow-up status and final treatment outcomes, including treatment completion, death, loss to follow-up (LTFU), and presence of neurological sequelae according to the Marais consensus diagnostic criteria

    Time frame: During TB treatment, an average 8-12 months

  6. The proportion of TBM disease severity, treatment, and outcomes, based on age group, HIV status, drug resistance status

    Time frame: During TB treatment, an average 8-12 months

07

Study locations

5 of 6 sites recruiting
  • Site 520: RSUP Prof Dr I.G.N.G. Ngoerah
    Denpasar, Bali 80113, Indonesia
    Not yet recruiting
    • dr. Anak Agung Ayu Suryapraba Indradewi Karang, Sp.N(K) · Contactsuryaprabaindradewi@unud.ac.id · +628572959815
    • dr. Anak Agung Ayu Suryapraba Indradewi Karang, Sp.N(K) · Principal investigator
    • Dr. dr. Ni Made Susilawathi, Sp.N(K) · Sub investigator
  • Site 701: RS Pusat Otak Nasional Prof. Dr. dr. Mahar Mardjono (RSPON)
    Jakarta, DKI Jakarta 13630, Indonesia
    Recruiting
    • dr. Hendro Birowo, Sp.N, Subsp.NKI(K) · Contacthe_bir@yahoo.com · +62 81310582682
    • dr. Hendro Birowo, Sp.N, Subsp.NKI(K) · Principal investigator
    • dr. Adisresti Diwyacitta, Sp.N · Sub investigator
    • dr. Winda Kusumadewi, Sp.N · Sub investigator
    • dr. Nugroho Harry Susanto, M.KM, PhD · Sub investigator
  • Site 540: RS Penyakit Infeksi Prof. Dr. Sulianti Saroso (RSPI SS)
    Jakarta, DKI Jakarta 14340, Indonesia
    Recruiting
    • dr. Maria Lawrensia Tampubolon, Sp.S · Contactmarianeuro26@gmail.com · +62 81210457821
    • dr. Maria Lawrensia Tampubolon, Sp.S · Principal investigator
    • Dr. dr. Nina Mariana, Sp.FK · Sub investigator
    • Siti Maemun, M.Epid · Sub investigator
  • Site 704: RSUP dr Johannes Leimena
    Ambon City, Maluku 97234, Indonesia
    Recruiting
    • dr. Muthia Marwah, Sp.S · Contactmuthianeuro@gmail.com · +62 813-2892-1986
    • dr. Muthia Marwah, Sp.S · Principal investigator
    • Mutmainna Burhanuddin, SKM · Sub investigator
  • Site 702: RSUP dr Mohammad Hoesin
    Palembang, South Sumatra 30126, Indonesia
    Recruiting
    • dr. Andika Okparasta, Sp.N, Subsp. N. K. I (K) · Contactandikaazizah@gmail.com · +62 812-7119-6332
    • dr. Andika Okparasta, Sp.N, Subsp. N. K. I (K) · Principal investigator
    • dr. Masita Masita, Sp.N, Subsp. NIITCC (K) · Sub investigator
  • Site 703: RSUP dr M Djamil
    Padang, West Sumatra 25129, Indonesia
    Recruiting
    • Dr. dr. Fanny Adhy Putri, Sp.N, Subsp.N.K.I.(K) · Contactfannyadhyputri@gmail.com · +62 852-6364-6367
    • Dr. dr. Fanny Adhy Putri, Sp.N, Subsp.N.K.I.(K) · Principal investigator
    • Dr. dr. Restu Susanti, Sp.N, Subsp.NN(K), M.Biomed · Sub investigator
    • dr. Dedi Sutia, Sp.N, Subsp.NIIOO(K) FINA, MAR · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Aug 2027, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2026
First posted
Nov 10, 2026
StartActual
Sep 24, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07929519
Lead sponsor
Ina-Respond
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Directorate General of Advanced Healthcare, Ministry of Health Republic of Indonesia, Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
Responsible party
Sponsor
First posted
Nov 10, 2026
Start date
Sep 24, 2026
Primary completion
Aug 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

dr. M. Helmi Aziz, M.Sc., Sp.MK
Contact
mhazis@ina-respond.net
+62 858-5458-0905
dr. Robert Sinto, SpPD,, K-PTI, DPhil, FINASIM, FHEA
principal investigator · Indonesia Research Partnership on Infectious Disease (INA-RESPOND)
dr. Maria Lawrensia Tampubolon, Sp.S
principal investigator · RS Penyakit Infeksi Prof. Dr. Sulianti Saroso (RSPI SS), Jakarta
dr. Hendro Birowo, Sp.N, Subsp.NKI(K)
principal investigator · RS Pusat Otak Nasional Prof. Dr. dr. Mahar Mardjono (RSPON), Jakarta
View the source record on ClinicalTrials.gov ↗

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