Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT05268718
Status:
UNKNOWN
Last Update Posted:
2022-03-07
First Post:
2022-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003320', 'term': 'Corneal Ulcer'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2022-02-24', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anterior segment photography', 'timeFrame': '1 month', 'description': 'corneal edema, keratohelcosis, hppopyon'}, {'measure': 'confocal microscopy', 'timeFrame': '1 month', 'description': 'fungal hyphae in corneal surface'}], 'secondaryOutcomes': [{'measure': 'eye pressure', 'timeFrame': '1 month', 'description': 'Measurement of contact tonometry with iCare TA01i tonometer after treatment (1 day, 1 week, 1 month)'}, {'measure': 'visual acuity', 'timeFrame': '1 month', 'description': 'Measurement of distance visual acuity with subjective refraction after treatment (1 week, 1 month)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Photothermal Therapy', 'Keratitis, Ulcerative', 'Antibiotic Resistance, Microbial'], 'conditions': ['Keratitis, Ulcerative', 'Antibiotic Resistance, Microbial', 'Photothermal Therapy']}, 'descriptionModule': {'briefSummary': 'This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The monocular cases of severe infectious keratitis admitted to our center were diagnosed as fungal keratitis according to their medical history, physical signs and surface secretions smear examination of corneal ulcer lesions (severe was defined as subjects with visual acuity \\< 0.15, deep stromal infiltration or involvement diameter \\>2mm, with extensive infiltration around or with extensive suppuration)\n2. After more than 2 weeks of active treatment with antibiotics, there was no effect\n3. The researchers communicated with the subjects in detail, and the subjects cooperated well and they voluntarily participated and signed informed consent\n\nExclusion Criteria:\n\n1. Allergic to the drug in this test.\n2. Pregnant and lactating women.\n3. The medical history suggests serious heart, lung, liver, kidney dysfunction.\n4. Patients with other factors that would affect the results of this result.\n5. No signed informed consent.'}, 'identificationModule': {'nctId': 'NCT05268718', 'briefTitle': 'Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Gold-silver-cuprous Oxide (Au-Ag-Cu2O) Composite Nanogel Combined With Photothermal Therapy in the Treatment of Severe Drug-resistant Microbial Keratitis', 'orgStudyIdInfo': {'id': '2021-0635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nanogel photothermal therapy', 'description': 'After the subjects were enrolled in the study, the eyes were coated with Au-Ag-Cu2O nano-gel once (the concentration was 26.4μg/mL, the dosage was suitable to cover the ulcer surface evenly, and the dosage was recorded). Combined with mdl-n-808-10w near-infrared laser (China changchun new industry photoelectric technology) combined with photothermal therapy (laser wavelength 808 nm, power 1.5W/cm2, temperature controlled at 40℃, lasting 10min)', 'interventionNames': ['Drug: Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voriconazole eye drops', 'description': 'Voliconazole eye drops (once in half an hour) were also used in the control group.', 'interventionNames': ['Drug: Voriconazole eye drops']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Normal saline eye drops (once in half an hour) were also used in the control group.', 'interventionNames': ['Other: Normal saline']}], 'interventions': [{'name': 'Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel', 'type': 'DRUG', 'otherNames': ['Au-Ag-Cu2O nano-gel'], 'description': 'Hollow gold and silver alloy cuprous oxide shell nano-shell hydrogel was excited by NIR laser to release functional silver ions, copper ions and ROS.', 'armGroupLabels': ['Nanogel photothermal therapy']}, {'name': 'Voriconazole eye drops', 'type': 'DRUG', 'otherNames': ['VRC'], 'description': 'Voriconazole eye drops (1%) were administrated to infectious eye very frequently (once half an hour)', 'armGroupLabels': ['Voriconazole eye drops']}, {'name': 'Normal saline', 'type': 'OTHER', 'otherNames': ['NS'], 'description': 'To be placebo, normal saline were administrated to infectious eye', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yue Qiao, PhD', 'role': 'CONTACT', 'email': 'qiaosensei@zju.edu.cn', 'phone': '+8619818504850'}], 'facility': 'Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Yue Qiao, PhD', 'role': 'CONTACT', 'email': 'qiaosensei@zju.edu.cn', 'phone': '+8619818504850'}], 'overallOfficials': [{'name': 'Ke Yao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Affiliated Hospital of Zhejiang University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}