Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-08 @ 5:20 AM
Study NCT ID:
NCT02503761
Status:
COMPLETED
Last Update Posted:
2015-07-21
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-11-02', 'releaseDate': '2016-09-14'}], 'estimatedResultsFirstSubmitDate': '2016-09-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-17', 'studyFirstSubmitDate': '2015-06-09', 'studyFirstSubmitQcDate': '2015-07-17', 'lastUpdatePostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcome', 'timeFrame': '15-28 days from Meropenem treatment', 'description': '* Success is defined as complete or partial resolution of leukocytosis, temperature, and clinical signs and symptoms of infection.\n* Failure consists of persistence or progression of signs and symptoms of infection, development of new clinical findings consistent with active infection, or death from infection.'}, {'measure': 'Microbiological outcome', 'timeFrame': '7-21 days from Meropenem treatment', 'description': '* Success is defined as eradication of infection or colonization which means detection of a new pathogen from the site of infection during meropenem therapy and no new antibiotic is indicated\n* Failure is defined as persistence of infection and superinfection which means detection of a new pathogen from the site of infection during meropenem therapy and new antibiotic is indicated.'}], 'secondaryOutcomes': [{'measure': 'Meropenem-related length of mechanical ventilation', 'timeFrame': '0-31 days from Meropenem treatment', 'description': 'The number of mechanical ventilation days from the start of meropenem administration'}, {'measure': 'Meropenem-related length of NICU stay', 'timeFrame': '10 weeks from Meropenem treatment', 'description': 'The number of days from the beginning of meropenem therapy to discharge from NICU'}, {'measure': 'NICU mortality', 'timeFrame': '12 weeks from time of admission', 'description': 'Death before discharge'}, {'measure': 'Duration of meropenem treatment', 'timeFrame': '3-28 days', 'description': 'Total days of meropenem treatment'}, {'measure': 'Clinical side effects of meropenem treatment', 'timeFrame': '3-28 days from meropenem treatment', 'description': 'Safety of meropenem therapy will be evaluated by clinical symptoms (diarrhea, rash, vomiting and seizures).'}, {'measure': 'Laboratory derangement related to meropenem treatment', 'timeFrame': '3-28 days from meropenem treatment', 'description': 'Assessment of laboratory parameters and their changes during meropenem therapy (transaminases, alkaline phosphatase, bilirubin).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['meropenem', 'infusion', 'late-onset sepsis', 'newborn', 'management'], 'conditions': ['Late Onset Neonatal Sepsis']}, 'referencesModule': {'references': [{'pmid': '27918382', 'type': 'DERIVED', 'citation': 'Shabaan AE, Nour I, Elsayed Eldegla H, Nasef N, Shouman B, Abdel-Hady H. Conventional Versus Prolonged Infusion of Meropenem in Neonates With Gram-negative Late-onset Sepsis: A Randomized Controlled Trial. Pediatr Infect Dis J. 2017 Apr;36(4):358-363. doi: 10.1097/INF.0000000000001445.'}]}, 'descriptionModule': {'briefSummary': 'Newborns in the neonatal intensive care unit (NICU), especially premature ones with immature organ systems, frequently suffer nosocomial infections caused by microorganisms resistant to narrow-spectrum antibiotics like ampicillin and gentamicin and require introduction of new agents with a wider spectrum of activity.\n\nMeropenem has activity against wide variety of Gram-negative and Gram-positive bacteria. It is well tolerated by children and neonates, including preterm babies, and allowing monotherapy instead of combined therapy.\n\nSevere neonatal infections with increasing antibiotic resistance are major problems affecting morbidity and mortality in the NICU. Few number of new antibacterial agents entering the clinic and new agents for multi-drug resistant Gram-negative bacteria will unlikely be available in the near future.', 'detailedDescription': 'More research into existing antibiotics with novel mechanisms of action are required to combat the increased resistance and decreased development of antibiotics. Efforts were exerted to maximize antibiotic efficacy by optimal dosing based on pharmacodynamic and pharmacokinetic properties of antibiotics.\n\nMeropenem is administered mostly via a 30-min infusion, as some data indicate rapid degradation after reconstitution. Dose recommendations from two pediatric studies using Monte Carlo simulation have emphasized that a 4-h infusion may be needed if microorganisms showed increased minimal inhibitory concentrations (MICs), more specifically, for Pseudomonas aeruginosa. A prolonged-infusion strategy has not been tested in neonates, although some data suggest that extremely small infusion volumes may significantly affect the drug amount actually delivered.\n\nAim of work:\n\nThe objective of our study is to compare the clinical and bacteriological efficacy of conventional intermittent dosing of meropenem to the prolonged infusions in critically-ill neonates, with a proactive focus on reducing ventilator days in ventilated patients, length of stay in NICU, and neonatal mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates admitted to the neonatal care unit (NCU) who suffer from late onset sepsis (LOS) at admission or during their NICU stay and receive meropenem for at least four days\n\nExclusion Criteria:\n\n* Acute or chronic renal failure\n* Hypersensitivity or allergy to meropenem'}, 'identificationModule': {'nctId': 'NCT02503761', 'acronym': 'BVPIMNBLOS', 'briefTitle': 'Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Bolus Versus Prolonged Infusion of Meropenem in Newborn With Late Onset Sepsis: A Randomized Control Trial', 'orgStudyIdInfo': {'id': '67890'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Infusion arm', 'description': 'Infants will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection. Each dose will be infused over four hours.', 'interventionNames': ['Drug: Meropenem.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bolus group', 'description': 'Infants will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection. Each dose will be infused over thirty minutes.', 'interventionNames': ['Drug: Meropenem.']}], 'interventions': [{'name': 'Meropenem.', 'type': 'DRUG', 'description': 'Infants in both groups will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection', 'armGroupLabels': ['Bolus group', 'Infusion arm']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor, PhD', 'investigatorFullName': 'Abd Elazeez Attala Shabaan', 'investigatorAffiliation': 'Mansoura University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-09-14', 'type': 'RELEASE'}, {'date': '2016-11-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Abd Elazeez Attala Shabaan, Assistant professor, PhD, Mansoura University'}}}}