[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cytomegalovirus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cytomegalovirus":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,69,166],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100336842","early-phase-1-donor-virus-specific-cmv-or-adv-ctl-to-treat-cmv-or-adv-reactivation-or-disease-after-solid-organ-or-hct-100336842",false,"NCT03665675","Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT","Pilot Study of Haploidentical or Matched Donor Virus-Specific T-cells (Cytomegalovirus (CMV) or Adenovirus (AdV)) to Treat CMV or AdV Reactivation or Disease in Patients After Solid Organ or Hematopoietic Stem Cell Transplantation (HCT)","Inclusion Criteria:\n\n* Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant.\n* • Cohort A (CMV): Must have documented CMV disease or reactivation, as by:\n\n  * Viremia as detected by quantitative polymerase chain reaction (PCR) (\\> 500 IU\u002Fml) in the peripheral blood requiring treatment OR\n  * High risk for antiviral failure due to history of recurrent CMV reactivations or evidence of antiviral drug resistance, OR\n  * Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury\n\n    • Cohort B (AdV): Must have documented AdV infection or reactivation, as by:\n  * Symptomatic subject with any detectable viral load in blood, OR\n  * Symptomatic subject with qualitative AdV detection in compartment of current symptomatology, including stool, urine, and\u002For other specimens (bronchoalveolar lavage (BAL), nasal swab, CSF, etc.), irrespective of blood viral load, OR\n  * New, persistent, and\u002For worsening AdV-related symptoms, signs, and\u002For markers of end organ compromise while receiving antiviral therapy (ie cidofovir), OR\n  * Asymptomatic with a viral load \\> 1000 copies\u002Fml in peripheral blood, OR\n  * Unable to tolerate antiviral treatment due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytopenia or neutropenia requiring growth factor support or other related organ injury\n\n    * Karnofsky (age \\> 16 years) or Lansky performance score \\> 70 (age \\\u003C 16)\n    * Available seropositive haploidentical or matched donor who is without evidence of infection that would otherwise preclude donation\n    * Negative pregnancy test in female patients if applicable (childbearing potential, has not received a full-intensity conditioning regimen\n    * Written informed consent and\u002For signed assent line from patient, parent or guardian\n    * DONOR\n    * Human leukocyte antigen (HLA)-haploidentical or full-match to the patient as determined by institutional standards\n    * Cohort A: CMV seropositive, defined as detection of serum CMV immunoglobulin G (IgG)\n    * Cohort B: AdV seropositive, defined as detection of serum AdV IgG\n    * Age 18 or over\n    * Meet donor eligibility or suitability according to institutional standards. If the donor is deemed ineligible according to Foundation for the Accreditation of Cellular Therapy (FACT) standards, but is suitable for donation per institutional standards, the donor will be eligible for the protocol\n\nExclusion Criteria:\n\n* Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 21 days of screening for enrollment.\n* Receipt of \\> 0.5mg\u002Fkg\u002Fday of prednisone or steroid equivalent at the time of enrollment. Stable GVHD is permitted as long as patients are on stable dose steroids of less than or equal to 0.5 mg\u002Fkg\u002Fday of prednisone or steroid equivalent.\n* Evidence of uncontrolled infection as follows:\n\n  * Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment.\n  * Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment.\n  * Patients with hemodynamic instability attributable to bacterial sepsis or new symptoms, worsening physical signs or radiographic findings attributable to concomitant bacterial or fungal infection are excluded. Patients who require ventilator support for CMV pneumonitis are not excluded. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.\n* Receipt of donor lymphocyte infusion (DLI) within 28 days.\n* Patients with active acute graft versus host disease (GvHD) grades II-IV requiring \\> 0.5 mg\u002Fkg\u002Fday of prednisone or steroid equivalent or T-cell depleting immunosuppression.\n* Acute graft rejection in solid organ transplantation requiring augmented immunosuppression with T-cell depleting agents or steroids as mentioned above.\n* Active and uncontrolled relapse of malignancy.",true,"ALL","1 Year","85 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \\[CMV\\] specific cytotoxic T-lymphocytes \\[CTLs\\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \\[AdV\\] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.",[28,29,30,31,32],"Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Cytomegalovirus","Donor","Solid Organ Transplantation Recipient","Adenovirus","RECRUITING","2026-04-10",{"date":36,"type":37},"2026-04-15","ACTUAL",{"date":39,"type":37},"2020-11-07",{"date":41,"type":22},"2026-12-20",{"name":43,"class":44},"Sumithira Vasu","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100490284","phase-2-haplo-identical-viral-specific-t-cells-for-treatment-of-cytomegalovirus-and-adenovirus-infections-after-hematopoietic-cell-transplantation-100490284","NCT05664126","Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation","Inclusion Criteria for Patients:\n\n* Patients who have undergone haploidentical HCT or a matched-sibling\u002Fmatched-unrelated donor HCT, and have CMV and\u002For ADV detected by PCR in the peripheral blood refractory to antiviral therapy per institutional BMTCT SOP 20.05.\n* Definition of \"refractory\" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy number (≥1 log) after 7 days of treatment.\n* Patients have no suspected or confirmed GVHD.\n* Availability of haploidentical donor for isolation of virus-specific T-cells.\n* Have not received a Donor Lymphocyte Infusion in the past 4 weeks.\n* Female patients of childbearing age must have a negative pregnancy test.\n* Subject, parent, or guardian are capable of giving signed informed consent.\n* Patients must have a shortening fraction \\>26% or left ventricular ejection fraction \\>40%.\n* Patients must have a bilirubin less than or equal to 2.5mg\u002FdL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.\n* Patients must have an estimated glomerular filtration rate (GFR) greater than 60mL\u002Fmin\u002F1.73m2 (may use estimated GFR that is auto calculated in the EHR).\n* Patients must be free of severe infection which upon determination of the principal investigator precludes therapy with VST.\n* Patients must have FVC \\>50% predicted or able to maintain pulse oximetry saturation \\> 92% on room air.\n* Gut diarrhea \\\u003C1 liter\u002Fday (adults) or \\\u003C20mL\u002Fkg\u002Fday (children) or if unable to quantify, then occurrence of 4 stools per day above baseline.\n* Patients must have engrafted with an ANC \\>500 cells\u002Fmm3 for 3 consecutive days.\n\nInclusion criteria for donors\n\n* Age ≥18 years.\n* At least single haplotype matched (≥3\u002F6) family member.\n* Donor will be identical to the stem cell donor (Cohort A) or different from the stem cell donor (Cohort B).\n* HIV negative.\n* For females of childbearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND not lactating with intent to breastfeed.\n* Regarding donation eligibility, is identified as either having completed the process of donor eligibility determination as outlined in 21CFR 1271 and agency guidance or does not meet 21CFR 1271 eligibility requirements but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21CFR.\n* Identified recipient with CMV and\u002For ADV reactivation post-HCT.\n\nExclusion Criteria for Patients:\n\n* Active GVHD.\n* Pregnancy.\n* Inability to provide consent.\n* Need for vasopressor or ventilatory support Patients receiving steroids \\>0.5 mg\u002Fkg prednisone equivalent at the time of VST infusion\n* Donor Lymphocyte Infusion within 4 weeks prior to VST infusion.\n* Receipt of Thymoglobulin or Alemtuzumab within 30 days of VST infusion.\n* Other severe uncontrolled concurrent infections (i.e. bacterial or fungal) that are not yet controlled on antimicrobial therapies.","18 Years",{"count":54,"type":22},42,[56],"PHASE2","The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at St. Jude in treating the participant's infection.\n\nPrimary objective\n\nTo determine the efficacy of VSTs to achieve a ≥1 log10 reduction in CMV and\u002For ADV viral load in the peripheral blood 4 weeks after VST infusion.\n\nWhen the initial viral load is \\\u003C1 log10 above the threshold of detection, the objective is to achieve a reduction to below the threshold of detection.\n\nSecondary objectives\n\n* Determine the safety of VSTs when used to treat CMV and\u002For ADV viremia post-HCT.\n* Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion.\n* Assess the persistence of response for 6 months post-infusion.",[29,32],"2026-02-19",{"date":61,"type":37},"2026-02-23",{"date":63,"type":37},"2023-08-01",{"date":65,"type":22},"2029-12-31",{"name":67,"class":44},"St. Jude Children's Research Hospital",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":16,"sex":17,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":139,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":68},"100620537","risk-assessment-of-community-spread-of-multiple-endemic-infectious-diseases-in-a-one-health-perspective-100620537","NCT07358910","Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective","RACSMEI","Inclusion Criteria:\n\n* Residency in the village for more than 6 months;\n* Age between 2 and 75 years old at the time of inclusion;\n* For adults: provision of written consent;\n* For children aged 2-17 years: written parental consent form, verbal assent from children aged 13-17 years;\n\nExclusion Criteria:\n\n* Unable to understand or consent;\n* Under guardianship or deprived of liberty;\n* Medical conditions that impede survey participation;\n* Refusal to participate in the study.","2 Years","75 Years",{"count":79,"type":22},10000,"OBSERVATIONAL","RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.\n\nRACSMEI will improve understanding across multiple pathogens using a multidisciplinary One Health approach. We will answer key questions on burden, ecology, transmission and population immune status to inform targeted and culturally appropriate interventions. The project combines a nationally representative One Health survey, social-science methods, and multiplex, diverse diagnostics to efficiently test for 57 priority pathogens, including zoonotic and vector-borne agents, vaccine-preventable and elimination-targeted diseases, enteric, respiratory, and environmentally transmitted pathogens and selected neglected tropical diseases and parasites relevant to Cambodia.\n\nMathematical modelling will reconstruct and forecast transmission dynamics and assess the potential impact of future public-health strategies. By integrating intersectoral data and innovative methods, RACSMEI will generate actionable evidence for public-health authorities, support precision One Health interventions, and help reduce disease burden in affected communities. The project also aims to ensure the transferability of methods and insights to other countries facing similar challenges.",[83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,32,117,118,119,29,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138],"Dengue","Chikungunya","Zika Virus Infection","Japanese Encephalitis","West Nile Virus","Tick-borne Encephalitis (TBE)","Severe Fever With Thrombocytopenia Syndrome","Nipah Virus Infection","Hantavirus Infections","Hepatitis E","Brucellosis","Q Fever","Leptospirosis","Melioidosis","Influenza A and B","Malaria","Yellow Fever","Mayaro Fever","Usutu Virus Infection","Oropouche Fever","Rift Valley Fever","Arenavirus Infections","Measles","Mumps","Rubella","Human Papilloma Virus (HPV)","Rotavirus Disease","Pertussis","Diphteria","Tetanus","Varicella","Hepatitis A","Norovirus Infections","Enterovirus","Rhinovirus","Parvovirus","Respiratory Syncytial Virus (RSV)","Epstein Barr Virus","Salmonella Typhi","Vibrio Cholerae","Legionella Pneumophila Pneumonia","Mycoplasma","Chlamydia","Lymphatic Filariasis","Toxoplasma Gondii","Giardiasis","Entamoeba Histolytica","Leishmaniasis","Strongyloides Stercoralis Infection","Ascaris Lumbricoides","Trichuris Trichiura","Clonorchis Sinensis","Opisthorchis Viverrini","Schistosomiasis","Streptococcus Pneumoniae","Meningitis",[140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156],"Infectious disease","One Health","Population-based survey","Nationally representative survey","Seroepidemiology","Multiplex serology","Seroprevalence","Vector-borne diseases","Zoonoses","Vaccine-preventable diseases","Neglected tropical diseases","Transmission dynamics","Force of infection","Mathematical modelling","Spatial epidemiology","Precision public health","Cambodia","2026-01-14",{"date":159,"type":37},"2026-01-22",{"date":161,"type":37},"2025-12-18",{"date":163,"type":22},"2027-09-30",{"name":165,"class":44},"Institut Pasteur du Cambodge",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":77,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":178,"conditions":179,"keywords":184,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":45},"100589775","phase-4-strategic-help-with-immunoglobulin-to-enhance-protect-against-late-disease-cmv-100589775","NCT06958796","Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)","Exploratory Use of CMV Immunoglobulin in High Risk (D+R-) Transplant Recipients at the End of Antiviral Prophylaxis to Decrease the Risk of Late CMV Infection","SHIELD","Inclusion Criteria\n\n* High risk pretransplant CMV donor seropositive\u002Frecipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney (SLK) transplant recipients\n* Able to do routine blood testing (normal care for transplant recipients)\n* Written informed consent obtained from the subject before any trial-related procedures\n* Be ≥18 years and ≤75 years of age at time of consent\n\nExclusion Criteria\n\n* Any pre-transplant CMV serologic combinations besides CMV D+\u002FR-\n* Multi organ transplants (other than simultaneous liver-kidney transplant (SLK) recipients) or prior history of bone marrow or stem cell transplant\n* Lung, heart, small bowel, pancreas, or other non-kidney or non-liver transplant recipients\n* Transplant recipients treated for rejection within three months before the end of valganciclovir prophylaxis\n* Participation in another interventional clinical trial at time of consent or within 30 days prior to study consent\n* Transplant recipients with eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 (as they theoretically could be at higher risk for renal impairment with CMV immunoglobulin), poor transplant organ function (i.e. LFTs \\> twice the upper limit of normal in liver recipients), or who are on dialysis, or plasmapheresis, or who are relisted for transplant, or who might otherwise at risk of complications at the discretion of the local site investigator.\n* Those with a history of severe reaction to CMV immunoglobulin (e.g. CytoGam® or similar) or other human immunoglobulin preparations\n* Individuals with a history of selective immunoglobulin A deficiency will be excluded, as they may produce antibodies against immunoglobulin A, leading to potential anaphylactic reactions upon receiving blood products containing immunoglobulin A, such as CMV immunoglobulin (e.g. CytoGam® or similar)\n* Any history of acute myocardial infarction (within 12 months of screening), clinically significant arrythmia, or clinically significant ECG abnormality in the opinion of the investigator at time of screening\n* History of active or latent tuberculosis (except those who have completed a documented regimen for latent TB treatment) or severe pulmonary disease \\[e.g., severe pulmonary hypertension (WHO class IV)\\] that in the opinion of the investigator that may preclude their ability to safely tolerate study infusions\n* Any history of neurodegenerative disease, including dementia, or stroke with substantial residual disability (modified Rankin score ≥ 3)\n* Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.\n* Women of childbearing potential unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Medically acceptable birth control (contraceptives) includes but are not limited to: surgical sterilization (such as hysterectomy or \"tubes tied\"), approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Depo-Lupron, lmplanon), barrier methods (such as condom or diaphragm), an intrauterine device (IUD), abstinence from sex.\n* Any significant history of any treatment nonadherence or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk\n* Subjects who have any of the following laboratory values: eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 ; Hemoglobin \\\u003C8.0 g\u002FdL; Platelets \\\u003C50,000 cells\u002FuL; Absolute neutrophil count \\\u003C1,000 cells\u002FuL; Total bilirubin \\>2.5 x upper limit of normal; Alanine aminotransferase (ALT) \\>5 x upper limit of normal; Aspartate aminotransferase (AST)\\] \\>5 x upper limit of normal; CMV IgG negative in donor or positive in recipient",{"count":175,"type":22},80,[177],"PHASE4","This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and\u002For kidney transplant.",[29,180,181,182,183],"Organ Transplant","Kidney Transplant; Complications","Liver Transplant Complications","Simultaneous Liver-Kidney Transplantation; Complications",[185,186,187,188,189,190],"cytomegalovirus","valganciclovir","organ transplant","immunoglobulin","CMV","High Risk CMV",{"date":192,"type":37},"2025-12-22",{"date":194,"type":37},"2025-11-27",{"date":196,"type":22},"2028-05-31",{"name":198,"class":44},"Camille N. Kotton, MD"]