Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults: a Prospective Observational Protocol Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- To examine the prevalence of invasive GBS illness among non-pregnant people in Malaysia.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Repeated group B streptococcus that is isolated from the same patients in the same admission
- •Non-sterile site isolates (Urine, Vaginal swab)
结局指标
主要结局
To examine the prevalence of invasive GBS illness among non-pregnant people in Malaysia.
时间窗: 18 months
. 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.
To examine the prevalence of antibiotic resistance of invasive GBS isolates among non-pregnant people in Malaysia.
时间窗: 2 months
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).
次要结局
- 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)
研究者
AbdulRahman Mansoor Mohammed Muthanna
Research Assistant
Universiti Putra Malaysia