Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT02152358
Status:
COMPLETED
Last Update Posted:
2023-04-06
First Post:
2014-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PTH - Preemptive Treatment for Herpesviridae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D015774', 'term': 'Ganciclovir'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilator-free days at Day 60', 'timeFrame': '60 days'}], 'secondaryOutcomes': [{'measure': 'Day 60 mortality', 'timeFrame': '60 days'}, {'measure': 'ICU mortality', 'timeFrame': '60 days'}, {'measure': 'Hospital mortality', 'timeFrame': '60 days'}, {'measure': 'Duration of mechanical ventilation in survivors', 'timeFrame': '60 days'}, {'measure': 'Duration of ICU stay', 'timeFrame': '60 days'}, {'measure': 'Duration of hospital stay', 'timeFrame': '60 days'}, {'measure': 'Incidence of ventilator-associated pneumonia', 'timeFrame': '60 days'}, {'measure': 'Incidence of bacteremia', 'timeFrame': '60 days'}, {'measure': 'SOFA score', 'timeFrame': 'days 3, 5, 7, 14, 21 and 28'}, {'measure': 'Acute renal failure related to aciclovir or its placebo', 'timeFrame': '60 days'}, {'measure': 'Leucopenia related to ganciclovir or its placebo', 'timeFrame': '60 days'}, {'measure': 'Time to oropharyngeal negativation of HSV PCR', 'timeFrame': '30 days'}, {'measure': 'Time to blood negativation of CMV PCR', 'timeFrame': '30 days'}, {'measure': 'Incidence of herpetic bronchopneumonia', 'timeFrame': '60 days'}, {'measure': 'Incidence of active CMV infection', 'timeFrame': '60 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cytomegalovirus', 'Herpes simplex virus', 'ICU', 'mechanical ventilation', 'mortality', 'ventilator-free days', 'PCR'], 'conditions': ['Viral Pneumonia']}, 'referencesModule': {'references': [{'pmid': '31841577', 'type': 'DERIVED', 'citation': 'Luyt CE, Forel JM, Hajage D, Jaber S, Cayot-Constantin S, Rimmele T, Coupez E, Lu Q, Diallo MH, Penot-Ragon C, Clavel M, Schwebel C, Timsit JF, Bedos JP, Hauw-Berlemont C, Bourenne J, Mayaux J, Lefrant JY, Mira JP, Combes A, Wolff M, Chastre J, Papazian L; Preemptive Treatment for Herpesviridae Study Group, Reseau Europeen de recherche en Ventilation Artificielle Network. Acyclovir for Mechanically Ventilated Patients With Herpes Simplex Virus Oropharyngeal Reactivation: A Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):263-272. doi: 10.1001/jamainternmed.2019.5713.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to show that a preemptive treatment by ganciclovir (for positive CMV viremia) or aciclovir (for positive HSV oro-pharyngeal PCR) is able to increase the number of ventilator-free days at Day 60.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mechanical ventilation \\> 96 hrs and expected duration of mechanical ventilation of at least 2 days\n* positive blood CMV PCR (500 IU/ml) OR positive oropharyngeal HSV PCR\n* age \\> 18 years\n* informed consent\n* negative pregnancy test\n\nExclusion Criteria:\n\n* \\< 18 years\n* Receiving ganciclovir or aciclovir or another antiviral agent active against HSV/CMV\n* Had received antiviral agent active against HSV/CMV during the previous month\n* Hypersensitivity to aciclovir/ganciclovir\n* Pregnancy\n* Breast feeding\n* Bone marrow failure\n* Solid organ recipients\n* Bone marrow recipients\n* HIV positive patients\n* Receiving immunosuppressive agents\n* SAPS II \\> 75\n* Withdrawing/withholding\n* Neutropenia (\\< 500 mm3)\n* Thrombocytopenia (\\< 25 G/L)\n* ICU readmission'}, 'identificationModule': {'nctId': 'NCT02152358', 'acronym': 'PTH', 'briefTitle': 'PTH - Preemptive Treatment for Herpesviridae', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomized, Double-blinded Multicenter Trial', 'orgStudyIdInfo': {'id': '20126003312-30'}, 'secondaryIdInfos': [{'id': '2012-003312-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ganciclovir', 'description': 'Patients with a positive CMV PCR', 'interventionNames': ['Drug: Ganciclovir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ganciclovir placebo', 'description': 'Patients with a positive CMV PCR', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aciclovir', 'description': 'Patients with a PCR positive for HSV', 'interventionNames': ['Drug: Aciclovir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Aciclovir placebo', 'description': 'Patients with a positive PCR for HSV', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aciclovir', 'type': 'DRUG', 'description': 'Intravenous 15 mg/kg/d during 14 days', 'armGroupLabels': ['Aciclovir']}, {'name': 'Ganciclovir', 'type': 'DRUG', 'description': 'intravenous 10 mg/kg/d for 14 days', 'armGroupLabels': ['Ganciclovir']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Aciclovir placebo', 'Ganciclovir placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique - Hôpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Laurent Papazian, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHM - AMU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}