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

NCT05726006 | Unknown

• 1 other identifier: UPM-PhD AbdulRahman
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Invasive Infection; Diabetic Foot; Immunocompromised Patients; Group B Streptococcal Infections

Outcome Measures

Primary Outcomes (2)

• To examine the prevalence of invasive GBS illness among non-pregnant people in Malaysia.

  . The researcher will verify the participants' medical records. Data on demographic data, clinical information, and information about the treatment and diagnosis initiated by the attending physician will be collected from patient's medical records from the selected hospitals.

  18 months

• To examine the prevalence of antibiotic resistance of invasive GBS isolates among non-pregnant people in Malaysia.

  The disc diffusion (Kirby-Bauer) method will be used to determine the antimicrobial susceptibility of the GBS isolates to penicillin, ampicillin, clindamycin, erythromycin, vancomycin, tetracycline, azithromycin, ceftriaxone, cefotaxime, cefepime, ofloxacin, chloramphenicol, linezolid (Oxoid, Basingstoke, UK). Meanwhile, the E-test method will be used to determine the minimal inhibitory concentrations (MIC) of resistant strains. The diameter of inhibition zones will be measured, and MIC will be read based on the recently stated CLSI guideline (Clinical and Laboratory Standards Institute (CLSI), 2022).

  2 months

Secondary Outcomes (3)

• Detection of GBS Virulence and Pilus Genes

  3 months

• Detection of Capsular polysaccharides types of GBS using Multiplex PCR

  3 months

• Detection of Sequence Type (ST)

  3 mnths

Study Arms (1)

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.

Other: No Intervention in This study

Interventions

No Intervention in This study OTHER

No Intervention in This study

Non-pregnant adult patients with group B streptococcal infection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consist of all non-pregnant adult patients from the selected hospitals whom group B streptococcus were isolated from their clinical samples from sterile sites (blood, cerebrospinal fluid, internal tissue, pus aspirate, peritoneal dialysis fluid, bone biopsy, skin biopsy and bone marrow). Repeated GBS that is isolated from the same patients in the same admission and non-sterile site isolates will be excluded.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Faculty of Medicine and Health Sciences

Serdang, Selangor, 43400, Malaysia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bacteria strains will be isolated, cultivated, and identified in the hospital laboratories. Sterile samples will be cultured using automated blood culture systems.

MeSH Terms

Conditions

Diabetic Foot; Streptococcal Infections

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• AbdulRahman Muthanna, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AbdulRahman Muthanna, PhD

CONTACT

+60176971214; dr.abm1990@gmail.com

Mohd Nasir Mohd Nasir, PhD

CONTACT

+60192831580; mnasir@upm.edu.my

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: February 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

MY (1)