Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-01-03 @ 10:23 AM
Study NCT ID:
NCT02330432
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2014-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mycobacterium w in Patients With Severe Sepsis
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C080550', 'term': 'Mycobacterium w vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2014-12-26', 'studyFirstSubmitQcDate': '2014-12-31', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28-day', 'description': '28-day all-cause mortality'}], 'secondaryOutcomes': [{'measure': 'New onset organ dysfunction measured by delta SOFA (maximum minus baseline SOFA)', 'timeFrame': '28-day', 'description': 'Measured by delta SOFA (maximum minus baseline SOFA)'}, {'measure': 'Ventilator-free days', 'timeFrame': '28-day', 'description': 'Day off the mechanical ventilator'}, {'measure': 'Time-to-vasopressor withdrawal', 'timeFrame': '28-day'}, {'measure': 'ICU length of stay', 'timeFrame': '28-day'}, {'measure': 'Hospital length of stay', 'timeFrame': '28-day'}, {'measure': 'New-onset infection', 'timeFrame': '28-day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '25241089', 'type': 'RESULT', 'citation': 'Sehgal IS, Agarwal R, Aggarwal AN, Jindal SK. A randomized trial of Mycobacterium w in severe sepsis. J Crit Care. 2015 Feb;30(1):85-9. doi: 10.1016/j.jcrc.2014.08.012. Epub 2014 Aug 28.'}, {'pmid': '33852919', 'type': 'DERIVED', 'citation': 'Sehgal IS, Basumatary NM, Dhooria S, Prasad KT, Muthu V, Aggarwal AN, Pal A, Desai M, Chaudhry D, Supe PD, Kurmi P, Choudhuri R, Shah C, Agarwal R. A Randomized Trial of Mycobacterium w in Severe Presumed Gram-Negative Sepsis. Chest. 2021 Oct;160(4):1282-1291. doi: 10.1016/j.chest.2021.03.062. Epub 2021 May 7.'}]}, 'descriptionModule': {'briefSummary': 'Recent evidence suggests that sepsis continuum includes an immune paralytic state, which may play a significant role in sepsis. Mycobacterium w by its TLR4 agonist activity may help in restoring immunity, thereby improving outcomes in patients with severe sepsis.\n\nIn this randomized trial, the investigators propose to evaluate the efficacy of Mw in patients with severe sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with severe sepsis within 48 hours of first organ dysfunction\n\n* Cardiovascular system dysfunction: systolic blood pressure ≤90 mm Hg or the mean arterial pressure ≤70 mm Hg for at least one hour despite adequate fluid resuscitation or the use of vasopressors to maintain a systolic blood pressure or mean arterial pressure of \\>90 and \\>65 mm Hg, respectively\n* Renal dysfunction: urine output \\<0.5 ml/kg/hour for two consecutive hours despite adequate fluid resuscitation\n* Respiratory system dysfunction: PaO2/FiO2 ≤300 or ≤250 if lung sepsis\n* Hematologic dysfunction: platelet count \\<100,000/mm3 or decrease by 50% in the three days preceding enrollment\n* Unexplained metabolic acidosis: pH ≤7.30\n\nExclusion Criteria:\n\n* Pregnancy\n* Gram-positive culture\n* Only fungal infection as source of sepsis\n* Patients who received cardiopulmonary resuscitation\n* Those on immunosuppressive therapy\n* Those unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02330432', 'acronym': 'MISS', 'briefTitle': 'Mycobacterium w in Patients With Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Phase IIb Randomized, Double Blind, Two Arm, Controlled Clinical Trial of Mycobacterium W in Combination With Standard Therapy Versus Standard Therapy Alone in Sepsis', 'orgStudyIdInfo': {'id': 'Pulm/Mw/002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mycobacterium w group', 'description': 'Patients in the experimental arm (Mw) in addition to standard care will receive single daily dose of 0.3 mL of Mw (heat-inactivated Mw \\[0.5 × 10\\^9\\]; Cadila Pharma, Ahmedabad, India) in the deltoid region for 3 consecutive days', 'interventionNames': ['Biological: Mycobacterium w', 'Other: Best standard care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best standard care', 'description': 'Best standard care for sepsis', 'interventionNames': ['Other: Best standard care']}], 'interventions': [{'name': 'Mycobacterium w', 'type': 'BIOLOGICAL', 'description': 'Single daily dose of 0.3 mL of Mw (heat-inactivated Mw \\[0.5 × 10\\^9\\]; Immuvac, Cadila Pharma, Ahmedabad, India) in the deltoid region for 3 consecutive days', 'armGroupLabels': ['Mycobacterium w group']}, {'name': 'Best standard care', 'type': 'OTHER', 'description': 'Antibiotics as early as possible; Norepinephrine \\> vasopressin \\> epinephrine for hypotension; Blood glucose 140-180 mg/dL; DVT and stress ulcer prophylaxis; Low tidal volume mechanical ventilation; Standard VAP, CLABSI prevention bundles', 'armGroupLabels': ['Best standard care', 'Mycobacterium w group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Uttarakhand', 'country': 'India', 'facility': 'Department of Pulmonary Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak', 'class': 'OTHER'}, {'name': "St.John's National Academy of Health Sciences", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Additional Professor', 'investigatorFullName': 'Ritesh Agarwal', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}