ReclutandoNCT07929519Registro de ClinicalTrials.gov

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

Tuberculous Meningitis

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LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio: Observacional
Fase: No aplica / no indicada
Rango de edad: No especificado - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 300 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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).

Leer la descripción completa

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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

Población del estudio

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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No informado
Enmascaramiento: No informado

No intervention (observational study) OTHER

No intervention (observational study)

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

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

Plazo: During TB treatment, an average 8-12 months