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UnknownNCT05726006

Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults.

Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults: a Prospective Observational Protocol Study

Status
Unknown
Phase
Study type
Observational
Enrollment
133 (estimated)
Sponsor
Universiti Putra Malaysia · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Group B Streptococcus (GBS) infection is a potential aetiology of meningitis and septicemia in neonates, pregnant women and non-pregnant adults. Because the GBS disease burden is unknown in Malaysia, it is unlikely to receive much attention. This study aims to determine the prevalence of group B streptococcus isolated from non-pregnant adults, the Incidence, case-fatality ratio, antimicrobial susceptibility patterns, serotyping, genotyping and detection of the GBS virulence and pili genes from six major hospitals in Peninsular Malaysia.

Detailed description

This multicentre, prospective, observational study will be conducted in six major tertiary hospitals in Malaysia among Non-Pregnant Adults. At the same time, a retrospective study will be conducted on the selected hospitals to determine GBS strains and data. GBS isolates will be subjected to phenotyping, serotyping using Multiplex PCR, antimicrobial susceptibility testing and detection of GBS virulence and pilus genes. Seven housekeeping genes will be sequenced internally to perform multi-locus sequence typing (MLST). Findings from the study will contribute to improving clinical practice to diagnose and prevent GBS disease on time. The prudent use of antibiotics will be encouraged by monitoring antimicrobial resistance.

Conditions

Interventions

TypeNameDescription
OTHERNo Intervention in This studyNo Intervention in This study

Timeline

Start date
2020-02-01
Primary completion
2023-03-01
Completion
2023-12-01
First posted
2023-02-13
Last updated
2023-05-16

Locations

1 site across 1 country: Malaysia

Source: ClinicalTrials.gov record NCT05726006. Inclusion in this directory is not an endorsement.

Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults. (NCT05726006) · Clinical Trials Directory