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

NCT ID: NCT05726006

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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

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Invasive Infection Diabetic Foot Immunocompromised Patients Group B Streptococcal Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-pregnant adult patients with group B streptococcal infection

all non-pregnant adult patients from the selected hospitals whom group B streptococcus will be isolated from their clinical samples from sterile sites.

No Intervention in This study

Intervention Type OTHER

No Intervention in This study

Interventions

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No Intervention in This study

No Intervention in This study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Non-pregnant adult patients
* patients with group B streptococcus infection
* The clinical samples isolated from sterile sites (blood, cerebrospinal fluid, internal tissue, pus aspirate, peritoneal dialysis fluid, bone biopsy, skin biopsy and bone marrow).

Exclusion Criteria

* Repeated group B streptococcus that is isolated from the same patients in the same admission
* Non-sterile site isolates (Urine, Vaginal swab)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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AbdulRahman Mansoor Mohammed Muthanna

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AbdulRahman Muthanna, PhD

Role: PRINCIPAL_INVESTIGATOR

FACULTY OF MEDICINE AND HEALTH SCIENCES, UNIVERSITI PUTRA MALAYSIA (UPM)

Locations

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Faculty of Medicine and Health Sciences

Serdang, Selangor, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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AbdulRahman Muthanna, PhD

Role: CONTACT

+60176971214

Mohd Nasir Mohd Nasir, PhD

Role: CONTACT

+60192831580

Facility Contacts

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AbdulRahman Muthanna, PhD

Role: primary

0176971214

Other Identifiers

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UPM-PhD AbdulRahman

Identifier Type: -

Identifier Source: org_study_id

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