Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-26 @ 4:22 AM
Study NCT ID:
NCT03978559
Status:
UNKNOWN
Last Update Posted:
2019-09-12
First Post:
2019-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011020', 'term': 'Pneumonia, Pneumocystis'}], 'ancestors': [{'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016720', 'term': 'Pneumocystis Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077336', 'term': 'Caspofungin'}, {'id': 'D013444', 'term': 'Sulfisoxazole'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2022-07-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2019-06-05', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality to day 28', 'timeFrame': '28 days after randomization', 'description': 'The percentage of subjects death at study day 28. Those subjects discharged from ICU prior to day 28 were counted as alive at day 28'}], 'secondaryOutcomes': [{'measure': 'ICU Free Days to day 28', 'timeFrame': '28 days after randomization', 'description': 'defined as the number of days between randomization and day 28 in which the patient is not in the ICU (for any part of a day)'}, {'measure': 'Mean Ventilator Free Days to day 28', 'timeFrame': '28 days after randomization', 'description': 'Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.'}, {'measure': 'ICU mortality', 'timeFrame': 'through ICU discharge, an average of 14 days', 'description': 'The percentage of death subjects at ICU discharge'}, {'measure': 'hospital mortality', 'timeFrame': 'through hospital discharge, an average of 28 days', 'description': 'The percentage of death subjects at hospital discharge'}, {'measure': 'PO2/FiO2 on day 7, 21', 'timeFrame': 'day 7, 21 after randomization', 'description': 'the change of PO2/FiO2 between baseline and day7, 21'}, {'measure': 'serum (1,3)-β-D gluca level on day 3, 7, 21', 'timeFrame': 'day3, 7, 21 after randomization', 'description': 'the change of (1,3)-β-D glucan level between baseline and day3, 7, 21'}, {'measure': 'PCP-DNA negative conversion rate in alveolar lavage fluid on day 7 after randomization', 'timeFrame': 'day 7 after randomization', 'description': 'the percentage of PCP-DNA negative after 7days treatment'}, {'measure': 'SOFA', 'timeFrame': 'day3, 7, 21 after randomization', 'description': 'respiratory dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score for respiratory system'}, {'measure': 'BALF cytokines level on day3, 7, 21', 'timeFrame': 'day3, 7, 21 after randomization', 'description': 'the change of cytokines in bronchoalveolar lavage fluid (BALF) level between baseline and day7, day21'}, {'measure': 'adverse events', 'timeFrame': 'till 21 days after randomization', 'description': 'incidence, duration and severity of adverse events'}, {'measure': 'serious adverse events', 'timeFrame': 'till 21 days after randomization', 'description': 'incidence, duration and severity of serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumocystis Pneumonia']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized clinical trial. During the study, non-HIV patients who are admitted to ICU due to Pneumocystic pneumonia (PCP) and have not received anti-PCP therapy or have received therapy less than 48hrs will be randomized (1:1) to received caspofungin combined with trimethoprim-sulfamethoxazole or trimethoprim-sulfamethoxazole alone.\n\nThe aim of this study is to compare the effectiveness of caspofungin combined with trimethoprim-sulfamethoxazole with that of conventional therapy (trimethoprim-sulfamethoxazole alone) as first-line therapy in the treatment of severe Pneumocystis pneumonia (PCP) in non-HIV patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Non-HIV immunosuppressed patients admitted to the ICU\n3. confirmed or suspect PCP\n\n3\\) Not receiving anti-PCP treatment or anti-PCP treatment \\< 48 hours\n\nExclusion Criteria:\n\n1. Age less than 18 years old\n2. Known pregnancy\n3. allergy to TMP/SMZ or caspofungin\n4. Decision to withhold life-sustaining treatment\n5. Patients with advanced pulmonary fibrosis\n6. severe liver dysfunction(Child-Pugh C )'}, 'identificationModule': {'nctId': 'NCT03978559', 'briefTitle': 'Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Prospective Randomized Controlled Study to Compare Efficacy of Caspofungin Combined With Trimethoprim-sulfamethoxazole Versus Trimethoprim/Sulfamethoxazole as First-line Therapy in Non-HIV Patients With Severe Pneumocystis Pneumonia', 'orgStudyIdInfo': {'id': 'MICU-PCP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAS with TMP/SMZ', 'interventionNames': ['Drug: caspofungin', 'Drug: TMP/SMZ(trimethoprim/sulfisoxazole)', 'Drug: Methylprednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TMP/SMZ', 'interventionNames': ['Drug: TMP/SMZ(trimethoprim/sulfisoxazole)', 'Drug: Methylprednisolone']}], 'interventions': [{'name': 'caspofungin', 'type': 'DRUG', 'description': 'caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days', 'armGroupLabels': ['CAS with TMP/SMZ']}, {'name': 'TMP/SMZ(trimethoprim/sulfisoxazole)', 'type': 'DRUG', 'description': 'TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days', 'armGroupLabels': ['CAS with TMP/SMZ', 'TMP/SMZ']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'description': '40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days', 'armGroupLabels': ['CAS with TMP/SMZ', 'TMP/SMZ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Du, Dr', 'role': 'CONTACT', 'email': 'dubin98@gmail.com', 'phone': '(8610)69155036'}], 'facility': 'MICU of Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Bin Du', 'role': 'CONTACT', 'email': 'dubin98@gmail.com', 'phone': '0086-10-69155036'}, {'name': 'JINMIN PENG', 'role': 'CONTACT', 'email': 'pjm731@hotmail.com', 'phone': '0086-10-69154040'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bin Du', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Bin Du', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}