Ignite Creation Date:
2025-12-26 @ 2:38 PM
Ignite Modification Date:
2025-12-29 @ 11:44 AM
Study NCT ID:
NCT05726006
Status:
UNKNOWN
Last Update Posted:
2023-05-16
First Post:
2023-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Bacteria strains will be isolated, cultivated, and identified in the hospital laboratories. Sterile samples will be cultured using automated blood culture systems.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 133}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine the prevalence of invasive GBS illness among non-pregnant people in Malaysia.', 'timeFrame': '18 months', 'description': ". 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."}, {'measure': 'To examine the prevalence of antibiotic resistance of invasive GBS isolates among non-pregnant people in Malaysia.', 'timeFrame': '2 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Detection of GBS Virulence and Pilus Genes', 'timeFrame': '3 months', 'description': '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'}, {'measure': 'Detection of Capsular polysaccharides types of GBS using Multiplex PCR', 'timeFrame': '3 months', 'description': '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).'}, {'measure': 'Detection of Sequence Type (ST)', 'timeFrame': '3 mnths', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Invasive Infection', 'Diabetic Foot', 'Immunocompromised Patients', 'Group B Streptococcal Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant adult patients\n* patients with group B streptococcus infection\n* The clinical samples isolated from sterile sites (blood, cerebrospinal fluid, internal tissue, pus aspirate, peritoneal dialysis fluid, bone biopsy, skin biopsy and bone marrow).\n\nExclusion Criteria:\n\n* Repeated group B streptococcus that is isolated from the same patients in the same admission\n* Non-sterile site isolates (Urine, Vaginal swab)'}, 'identificationModule': {'nctId': 'NCT05726006', 'briefTitle': 'Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults.', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Putra Malaysia'}, 'officialTitle': 'Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults: a Prospective Observational Protocol Study', 'orgStudyIdInfo': {'id': 'UPM-PhD AbdulRahman'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-pregnant adult patients with group B streptococcal infection', 'description': 'all non-pregnant adult patients from the selected hospitals whom group B streptococcus will be isolated from their clinical samples from sterile sites.', 'interventionNames': ['Other: No Intervention in This study']}], 'interventions': [{'name': 'No Intervention in This study', 'type': 'OTHER', 'description': 'No Intervention in This study', 'armGroupLabels': ['Non-pregnant adult patients with group B streptococcal infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43400', 'city': 'Serdang', 'state': 'Selangor', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'AbdulRahman Muthanna, PhD', 'role': 'CONTACT', 'email': 'dr.abm1990@gmail.com', 'phone': '0176971214'}], 'facility': 'Faculty of Medicine and Health Sciences', 'geoPoint': {'lat': 3.03333, 'lon': 101.71667}}], 'centralContacts': [{'name': 'AbdulRahman Muthanna, PhD', 'role': 'CONTACT', 'email': 'dr.abm1990@gmail.com', 'phone': '+60176971214'}, {'name': 'Mohd Nasir Mohd Nasir, PhD', 'role': 'CONTACT', 'email': 'mnasir@upm.edu.my', 'phone': '+60192831580'}], 'overallOfficials': [{'name': 'AbdulRahman Muthanna, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FACULTY OF MEDICINE AND HEALTH SCIENCES, UNIVERSITI PUTRA MALAYSIA (UPM)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Putra Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'AbdulRahman Mansoor Mohammed Muthanna', 'investigatorAffiliation': 'Universiti Putra Malaysia'}}}}