Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-30 @ 11:26 PM
Study NCT ID:
NCT01118403
Status:
WITHDRAWN
Last Update Posted:
2016-05-24
First Post:
2010-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D003128', 'term': 'Coma'}, {'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035444', 'term': 'sultamicillin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'He could not be started due to lack of funds', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-21', 'studyFirstSubmitDate': '2010-05-04', 'studyFirstSubmitQcDate': '2010-05-05', 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia', 'timeFrame': '2 years', 'description': 'To determine the impact of prophylaxis with ampicillin sulbactam versus placebo on the incidence of early ventilator-associated pneumonia in patients with altered level of consciousness with a score on the Glasgow Coma Scale less than or equal to 8 and requiring mechanical ventilation for more than 48 hours'}], 'secondaryOutcomes': [{'measure': 'Effect of antibiotic prophylaxis versus placebo on the incidence of other infections', 'timeFrame': '2 years', 'description': 'Compare the effect of antibiotic prophylaxis versus placebo on the incidence of later ventilator-associated pneumonia, as well as in other non-pulmonary infections (catheter sepsis, bacteremia, meningitis, urinary tract infection).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ventilator associated pneumonia', 'Coma', 'Brain Injuries', 'Intensive care units', 'antibiotic prophylaxis'], 'conditions': ['Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'This study seeks to assess whether coma patients really benefit from the use of antibiotics as a prophylactic for reducing the incidence of early ventilator-associated pneumonia in this population group. For this we consider the use of ampicillin sulbactam antibiotic which has a low ability to induce resistance, efficacy and safety observed during the time that has been used, even in patients with neurosurgical pathology, and to be broadly available in our environment.\n\nOur hypothesis is that neurological patients in coma state, requiring mechanical ventilation, the application of antibiotic prophylaxis compared with placebo reduces the incidence of early ventilator-associated pneumonia.', 'detailedDescription': 'Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections occur in intensive care units, with frequencies ranging between 15% and 45%, which determine an attributable mortality of 25% to 27%\n\nPatients with compromised state of consciousness brought to mechanical ventilation, have a much higher reported incidence that patients without neurological involvement, reaches between 44 and 70%.\n\nThese data have led to plan the implementation of strategies to reduce the incidence of early pneumonia in this population group, to thereby favorably influence the high rates of mortality, morbidity and costs that arise.\n\nThen we design this study to assess whether these patients really benefit from the use of antibiotics as a prophylactic, considering also the high impact that this would have given the high incidence of early ventilator-associated pneumonia in this population group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine.\n* Requiring mechanical ventilation for more than 48 hours\n* Includes all patients with structural or metabolic coma\n\nExclusion Criteria:\n\n* Pregnant women\n* History of allergic reactions to ampicillin sulbactam\n* Patients admitted as potential organ donors\n* Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously.\n* Hospital stay for more than 48 hours before intubation.'}, 'identificationModule': {'nctId': 'NCT01118403', 'acronym': 'NAVPRO', 'briefTitle': 'Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Pablo Tobón Uribe'}, 'officialTitle': 'Antibiotic Prophylaxis for Early Ventilator-associated Pneumonia in Neurological Patients: A Randomized Trial', 'orgStudyIdInfo': {'id': '58222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sultamicillin, Antibiotic Prophylaxis', 'description': 'Sultamicillin, Antibiotic Prophylaxis', 'interventionNames': ['Drug: Sultamicillin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Physiologic Sodium Chloride Solution', 'interventionNames': ['Drug: Sultamicillin']}], 'interventions': [{'name': 'Sultamicillin', 'type': 'DRUG', 'otherNames': ['Sulbactam Ampicillin', 'Unasyn'], 'description': 'Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution', 'armGroupLabels': ['Placebo', 'Sultamicillin, Antibiotic Prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Hospital Pablo Tobón Uribe', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'Carlos A Cadavid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Pablo Tobón Uribe'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Pablo Tobón Uribe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}