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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726006
• Other study ID #: UPM-PhD AbdulRahman
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: Universiti Putra Malaysia
• Contact: AbdulRahman Muthanna, PhD
• Phone: +60176971214
• Email: dr.abm1990[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. completion date: December 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetic Foot
• Group B Streptococcal Infections
• Immunocompromised Patients
• Infections
• Streptococcal Infections

Intervention

Other:
• No Intervention in This study
No Intervention in This study

Locations

Country	Name	City	State
Malaysia	Faculty of Medicine and Health Sciences	Serdang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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