NCT05173727

Brief Summary

Streptococcus Pneumoniae is one of the etiology in severe CAP and accounts for about 60-75% of cases and is likely to be the leading cause of unknown etiologic pneumonia. In Indonesia, studies regarding the prevalence of Streptococcus pneumoniae as the cause of CAP are still very rare. Therefore, there is still a need for further investigation in S. pneumoniae prevalence among hospitalized CAP by utilizing different detection methods in Indonesia. Antibiotics as a therapy of CAP also showed high levels of resistance, meanwhile, early detection of causative pathogen is potentially reducing the incidence of antibiotic resistance and usage of broad-spectrum antibiotics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

December 12, 2023

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

December 10, 2021

Last Update Submit

December 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Determine the distribution of Streptococcus pneumoniae serotype and its prevalence

    Determine the distribution of Streptococcus pneumoniae serotype and its prevalence isolated from hospitalized adult patients with CAP in Cipto Mangunkusumo Hospital, Jakarta, Indonesia utilizing different methods.

    Through study completion, an average of 2 year.

Secondary Outcomes (1)

  • To investigate the antibiotics susceptibility of Streptococcus pneumoniae

    Through study completion, an average of 2 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population target is the severe pneumonia patient in ED/ICU/HCU Cipto Mangunkusumo Hospital. The reachable population is moderate and severe CAP in ED/ICU/HCU, Cipto Mangunkusumo Hospital., Jakarta. The research subjects are the reachable population who meet the inclusion and exclusion criteria by consecutive sampling recruitment method

You may qualify if:

  • Hospitalized adult ≥ 18 years old
  • Moderate to severe CAP (CURB-65 score \> 2 dan ATS/IDSA 2019)

You may not qualify if:

  • Have been taking antibiotic more than 24 hours before enrollment.
  • Diagnose with non-infectious ARDS disease (such as aspiration pneumonia or cardiogenic pulmonary edema).
  • Diagnose with tuberculosis based on clinical or radiological findings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital - Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Location

MeSH Terms

Conditions

Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gurmeet Singh, MD, PhD

    Indonesian Society of Respirology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Division Respirology and Critical Illness, Internal Medicine Department, Principal Investigator, Respirology and Critical Illness Consultant

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 30, 2021

Study Start

May 15, 2022

Primary Completion

July 15, 2023

Study Completion

November 1, 2023

Last Updated

December 12, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations