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RecruitingNCT07929519ClinicalTrials.gov record

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

Tuberculous Meningitis

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Observational
Phase
Not applicable / not listed
Age range
Not specified - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
300 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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:

None

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
No intervention (observational study) OTHER

No intervention (observational study)

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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

Not reported in this registry record.

Secondary measures

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

Time frame: at hospital admission timepoint

Not reported in this registry record.

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

Not reported in this registry record.

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

Not reported in this registry record.

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

Not reported in this registry record.

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

Not reported in this registry record.

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

Not reported in this registry record.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (6)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

6 locations

Site 520: RSUP Prof Dr I.G.N.G. NgoerahDenpasar, Bali, IndonesiaNot 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
View location on map ↗
Site 701: RS Pusat Otak Nasional Prof. Dr. dr. Mahar Mardjono (RSPON)Jakarta, DKI Jakarta, IndonesiaRecruiting
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.NSUB_INVESTIGATOR
dr. Winda Kusumadewi, Sp.NSUB_INVESTIGATOR
dr. Nugroho Harry Susanto, M.KM, PhDSUB_INVESTIGATOR
View location on map ↗
Site 540: RS Penyakit Infeksi Prof. Dr. Sulianti Saroso (RSPI SS)Jakarta, DKI Jakarta, IndonesiaRecruiting
dr. Maria Lawrensia Tampubolon, Sp.SCONTACTmarianeuro26@gmail.com+62 81210457821
dr. Maria Lawrensia Tampubolon, Sp.SPRINCIPAL_INVESTIGATOR
Dr. dr. Nina Mariana, Sp.FKSUB_INVESTIGATOR
Siti Maemun, M.EpidSUB_INVESTIGATOR
View location on map ↗
Site 704: RSUP dr Johannes LeimenaAmbon City, Maluku, IndonesiaRecruiting
dr. Muthia Marwah, Sp.SCONTACTmuthianeuro@gmail.com+62 813-2892-1986
dr. Muthia Marwah, Sp.SPRINCIPAL_INVESTIGATOR
Mutmainna Burhanuddin, SKMSUB_INVESTIGATOR
View location on map ↗
Site 702: RSUP dr Mohammad HoesinPalembang, South Sumatra, IndonesiaRecruiting
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
View location on map ↗
Site 703: RSUP dr M DjamilPadang, West Sumatra, IndonesiaRecruiting
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.BiomedSUB_INVESTIGATOR
dr. Dedi Sutia, Sp.N, Subsp.NIIOO(K) FINA, MARSUB_INVESTIGATOR
View location on map ↗

Study team and timeline

Lead sponsor
Ina-Respond
Study start
Sep 24, 2026 Actual
Primary completion
Aug 31, 2027 Estimated
Study completion
Dec 31, 2027 Estimated
First posted
Nov 10, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

dr. M. Helmi Aziz, M.Sc., Sp.MKCONTACTmhazis@ina-respond.net+62 858-5458-0905
Official study title

Clinical Characteristics, Treatment, Diagnostic Findings, and Outcomes of Tuberculous Meningitis: A Retrospective Cohort Study in Indonesia, 2022-2025

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026