Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT01449916
Status:
TERMINATED
Last Update Posted:
2021-09-30
First Post:
2011-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Simplified Severe Sepsis Protocol in Zambia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'whyStopped': 'High mortality rate in intervention arm for patients with RR \\>40 AND SpO2 \\< 90%.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2011-10-05', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital all cause mortality', 'timeFrame': 'During hospitalization, expected average 14 days'}], 'secondaryOutcomes': [{'measure': '28-day all-cause mortality', 'timeFrame': '28-day'}, {'measure': 'In-hospital all cause mortality adjusted for illness severity', 'timeFrame': 'During hospitalization, expected average 14 days', 'description': 'Adjusted for SAPS3 score'}, {'measure': '28-day all cause mortality adjusted for baseline illness severity', 'timeFrame': '28-day', 'description': 'Adjusted for SAPS3 score'}, {'measure': 'Cumulative adverse events', 'timeFrame': 'During hospitalization, expected average 14 days', 'description': 'A composite outcome consisting of dopamine extravasation, dopamine-associated tissue ischemia or necrosis, iatrogenic pulmonary oedema, and transfusion-related adverse events.'}, {'measure': 'Treatment cost per patient', 'timeFrame': 'During hospitalization, expected average 14 days', 'description': 'A budget impact analysis will determine the cost of treatment per patient using a mix of direct measurements and micro-cost observation.'}, {'measure': 'Antibiotic changed due to culture results', 'timeFrame': 'During hospitalization, expected average 14 days', 'description': 'The proportion of patients whose antibiotic regimen was changed due to information obtained from blood culture results.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Severe Sepsis', 'Protocol', 'Zambia'], 'conditions': ['Sepsis', 'Severe Sepsis']}, 'descriptionModule': {'briefSummary': 'This study is a randomized control trial assessing the impact of a simple evidence-based protocol for the treatment severe sepsis in Zambia. The intervention protocol consists of a scheduled fluid regimen, early blood culture and antibiotics, and dopamine and blood transfusion when necessary. It is hypothesized that the protocol will significantly decrease in-hospital mortality in patients with severe sepsis.', 'detailedDescription': 'In recent years, evidence-based protocols of bundled therapies have improved survival of severe sepsis in developed countries. However, in sub-Saharan Africa, simple therapies such as IV fluids and early antibiotics are frequently under-utilized. Furthermore, although tuberculosis is a common cause of severe sepsis in the region, accurate and timely diagnosis of tuberculosis-associated severe sepsis remains elusive.\n\nThe aims of this study are (1) To assess the impact on survival of a simple evidence-based protocol for severe sepsis, (2) To evaluate the cost of implementation for a simplified severe sepsis protocol (3) To develop a clinical diagnostic score for identifying tuberculosis in HIV positive patients with severe sepsis (4) To assess the performance of the Xpert TB/RIF rapid PCR system for diagnosing tuberculosis in HIV positive patients with severe sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Suspected infection\n* 2 or more of SIRS criteria:\n\n * Heart rate \\>90/min\n * Respiratory rate \\>20/min\n * Temperature \\>= 38° C or \\<= 36° C\n * White blood count \\> 12,000 or \\< 4,000/µL\n* 1 or more of the following signs of end-organ dysfunction\n\n * Systolic blood pressure \\< 90 mm Hg\n * Mean arterial blood pressure (MAP) \\< 65 mm Hg\n * Confusion/altered mentation\n * Urine output \\< 0.5 mL/kg/hr\n * Creatinine increase \\> 0.5 mg/dL\n * Creatinine \\> 0.5 mg/dL above upper limit of normal\n * Platelet \\< 100x109/L\n * Respiratory rate \\> 40/min\n * Jaundice\n\nExclusion Criteria:\n\n* GI bleed\n* Need for urgent surgery'}, 'identificationModule': {'nctId': 'NCT01449916', 'acronym': 'SSSP', 'briefTitle': 'Simplified Severe Sepsis Protocol in Zambia', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Improving Sepsis Diagnosis and Treatment: Simplified Severe Sepsis Protocol (SSSP)', 'orgStudyIdInfo': {'id': 'SSSP'}, 'secondaryIdInfos': [{'id': 'R24TW007988', 'link': 'https://reporter.nih.gov/quickSearch/R24TW007988', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simplified Severe Sepsis Protocol', 'description': 'This protocol consists of an early aggressive fluid strategy, early blood cultures and antibiotics, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings.', 'interventionNames': ['Other: Simplified Severe Sepsis Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': "Early blood cultures and antibiotics. Monitoring by study nurses as in experimental arm. Other interventions are according to admitting (non-study) doctors' orders.", 'interventionNames': ['Other: Simplified Severe Sepsis Protocol']}], 'interventions': [{'name': 'Simplified Severe Sepsis Protocol', 'type': 'OTHER', 'description': 'Early fluid protocol, early blood cultures and antibiotics; blood cultures and titrated dopamine in selected patients; monitoring based on vital signs and physical examination', 'armGroupLabels': ['Simplified Severe Sepsis Protocol', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'country': 'Zambia', 'facility': 'University Teaching Hospital', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Benjamin L Andrews, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University and University of Zambia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}