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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot; Group B Streptococcal Infections; Immunocompromised Patients; Invasive Infection
• Intervention / Treatment: Other: No Intervention in This study

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.

• Study Type: Observational
• Enrollment (Anticipated): 133

Contacts and Locations

• Study Contact: Name: AbdulRahman Muthanna, PhD; Phone Number: +60176971214; Email: dr.abm1990@gmail.com
• Study Contact Backup: Name: Mohd Nasir Mohd Nasir, PhD; Phone Number: +60192831580; Email: mnasir@upm.edu.my

Study Locations

• Malaysia
  • Selangor
    • Serdang, Selangor, Malaysia, 43400
      • Recruiting
      • Faculty of Medicine and Health Sciences
      • Contact: AbdulRahman Muthanna, PhD; Phone Number: 0176971214; Email: dr.abm1990@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No Intervention in This study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of GBS Virulence and Pilus Genes	GBS virulence (cfb, cylE, lmb, scpB, hylB, rib, fbsA, fbsB, spb1, bca and bac) and pili genes (PI-1, PI-2a and PI-2b) will be amplified using PCR that performed on a BioRadMyCyclerTM Thermal Cycler (BioRad, Massachusetts, USA) using the primers and running conditions published previously	3 months
Detection of Capsular polysaccharides types of GBS using Multiplex PCR	GBS capsular serotypes will be deduced by the multiplex PCR method. Ten serotypes (Ia, Ib and II - IX) will be determined by targeting the cps gene cluster, including cpsL, cpsG, cpsJ-Ib, cpsJ-2, cpsG-3-6, cpsJ-4, cpsN-5, cpsI-6, cpsI-7, cpsJ-8, and cpsI-9 genes using published primers according to the study by Imperi et al. (2010).	3 months
Detection of Sequence Type (ST)	Multi-locus sequence typing (MLST) will be performed by sequencing the internal fragments of seven housekeeping genes (ashP, pheS, atr, glnA, sdhA, glcK and tkt), as previously described (Jones et al., 2003). The sequences of the seven housekeeping genes will be trimmed and aligned using Molecular Evolutionary Genetics Analysis version 7 (MEGA 7) software according to known alleles base pair as described in the MLST database website (http://pubmlst.org/) in order to determine the allelic number and sequence type (ST).	3 mnths

Collaborators and Investigators

• Sponsor: Universiti Putra Malaysia
• Investigators: Principal Investigator: AbdulRahman Muthanna, PhD, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia (UPM)

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): March 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Disease Attributes; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Foot Ulcer; Diabetic Foot; Infections; Communicable Diseases; Streptococcal Infections
• Other Study ID Numbers: UPM-PhD AbdulRahman

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No