Clinical trial NCT05726006: Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults.
Official title: Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults: a Prospective Observational Protocol Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Infection
Diabetic Foot
Immunocompromised Patients
Group B Streptococcal Infections
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: To examine the prevalence of invasive GBS illness among non-pregnant people in Malaysia.
timeFrame: 18 months
measure: To examine the prevalence of antibiotic resistance of invasive GBS isolates among non-pregnant people in Malaysia.
timeFrame: 2 months
Secondary outcomes:
measure: Detection of GBS Virulence and Pilus Genes
timeFrame: 3 months
measure: Detection of Capsular polysaccharides types of GBS using Multiplex PCR
timeFrame: 3 months
measure: Detection of Sequence Type (ST)
timeFrame: 3 mnths
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Faculty of Medicine and Health Sciences
state: Selangor
Study officials:
affiliation: FACULTY OF MEDICINE AND HEALTH SCIENCES, UNIVERSITI PUTRA MALAYSIA (UPM)
name: AbdulRahman Muthanna, PhD
role: PRINCIPAL_INVESTIGATOR
References: