A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection...
CMVCMV Infection1 moreThe purpose of this study is to determine of letermovir (LTC) is effective at preventing Cytomegalovirus (CMV) infection from returning in people who have already had CMV infection after a bone marrow transplant.
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative...
Gram-negative Bacterial InfectionsThe purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants. The study is seeking participants who are: 9 months to less than 18 years of age Hospitalized Suspected/known to have a gram-negative infection Receiving intravenous (iv, given directly into a vein) antibiotics Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs. Participants will receive either ATM-AVI or best available therapy (BAT). Both therapies will be given through a vein. Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). - Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion. The iv dose of ATM-AVI will be based on the participant's weight and kidney function. The study doctor will determine the iv dose of BAT. During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities. Starting on day 4, the study doctor will decide if participants may be switched to oral therapy. Participants will receive a maximum of 14 days of ATM-AVI treatment. After discharge from the hospital, 1 study visit may be required. Depending on the participant's response, the study duration will be from 33 to 50 days. The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.
Lianhua Qingke for the Rehabilitation of Patient With Omicron Infection
CoronavirusTraditional Chinese MedicineThe patients with Omicron infection usually have fever, respiratory symptoms, tachycardia, headache, toothache, muscle soreness, physical decline, and so on, while others are asymptomatic patients. It is urgent to find drugs to improve the long-term rehabilitation of symptomatic patients with Omicron infection and decrease the duration of viral shedding in both symptomatic and asymptomatic patients. This study aims to investigate the efficacy and safety of Lianhua Qingke tablets in patients with Omicron infection. The duration of viral shedding and symptoms will be evaluated. 6-month follow-up will be performed to evaluate the effect of Lianhua Qingke on long-term rehabilitation of all symptoms induced by Omicron infection, as well as infection events.
T Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections After...
Opportunistic Fungal InfectionOpportunistic Viral Infection1 moreThe purpose of the study is to determine the feasibility, safety and efficacy of administering rapidly-generated donor-derived pentavalent-specific T cells (Penta-STs) to mediate antiviral and antifungal activity in hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.
A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Multi-drug Resistant E....
Urinary Tract InfectionsThis is a Phase 2/3 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 550 patient portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline.
Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection...
BK Virus InfectionNephropathy1 moreThis is a Phase II, multicenter, open-label, randomized, standard of care (SOC) controlled, multiple ascending dose study to assess the safety and tolerability of IV Brincidofovir (BCV) in subjects with BKV infection after kidney transplantation. The study will be conducted at multiple study sites in several countries including Australia and Japan. Subjects who meet eligibility criteria will be enrolled in the study and will be randomized and assigned to BCV or SOC (defined as use of the same immunosuppressant administered during prescreening) before receipt of the first dose of study drug in both the Dose Escalation Phase and the Expansion Phase.
DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV...
Cervix DysplasiaHPV InfectionHuman papillomaviruses (HPV) are the most common sexually transmitted pathogens worldwide and in most cases are causally associated with the development of cervical cancer, one of the most common cancers in women and one of the leading causes of death in women worldwide. Precancerous lesions (dysplasias) or the presence of a high-risk HPV subtype are detected by a screening smear test performed by a gynecologist. If precancerous lesions are detected, conization (= surgical removal of a cone of tissue from the cervix) is the method of choice for removing the diseased tissue. However, if the degree of dysplasia is correspondingly low or the smear is unclear, then the guideline-compliant non-surgical treatment provides for a wait-and-see approach with PAP and HPV smear control after 6-8 months. This "wait-and-see" approach can be complemented by local therapy with an immunostimulant. For this purpose, DEFLAGYN® (a vaginal gel containing silica and citric acid) and Aldara® (imiquimod, a Toll-Like Re-ceptor 7 antagonist) are available. However, while the latter is not approved for the treatment of cervical dysplasia or HPV infection, DEFLAGYN® has CE marking and approval as a medical device for treatment in a number of indications, such as unclear cervical smears, HPV-induced cervical lesions, p16/Ki-67-positive cervical lesions or cervical erosions. However, available studies on the efficacy of DEFLAGYN are limited. For example, there is only one prospective randomized trial (Major et al, 2021, Arch. Gynecol. Obstet. 303:501-511), which included 216 women with histologically confirmed CIN 1/2. A 3-month intravaginal application of DEFLAGYN® resulted in regression of CIN 1/2 in 72% versus 25% in the control arm (no intervention). Side effects of therapy with DEFLAGYN® were not observed in this study. Due to the frequency of CIN and HPV infections in the female population and due to the high medical relevance of a conservative method of treating this disease, further methodologically high-quality studies on the efficacy of DEFLAGYN® should be performed.
Nutritional Supplement for Patients With Severe Infection
Severe InfectionThis is a randomized trial testing a supplement that has been approved by Health Canada to support healthy cholesterol levels (i.e. high density lipoprotein (HDL) cholesterol). This trial is proposing to use this approved supplement to determine whether it is able to raise HDL cholesterol in patients treated in the intensive care unit (ICU) with severe infection who have detrimentally low levels of HDL cholesterol. Patients who present to the ICU with severe infection will be approached for consent. If they choose to participate, patients will be given usual care or a 150mL daily nutritional supplement containing lauric acid (15 ml) and Berberine (1000 mg) daily for 14 days. Participants will be followed during their stay in the ICU and will receive follow up phone calls at Day 28 and 90.
A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy...
Multi-Drug Resistant Hiv-1 InfectionHIV-1 InfectionBackground: People with HIV usually take a combination of 2 or more anti-HIV drugs daily to help manage their infection. Sometimes, however, HIV becomes resistant to these drugs, and the infection cannot be treated. Untreated HIV infection can make people more vulnerable to other infections as well as some cancers. Better treatments are needed for people with drug-resistant HIV. Objective: To see if a study drug (UB-421) is effective in people with drug-resistant HIV. Eligibility: People aged 18 years and older with HIV that is resistant to anti-HIV drugs. Design: Participants will be in the study for 35 weeks. Participants will have separate screening and baseline visits within 2 months of each other. They will have a physical exam with blood and urine tests both times. On the second visit, they will undergo apheresis: Blood will be drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in the other arm. Participants will begin receiving the study drug 1 week after their baseline visit. UB-421 is given through a tube attached to a needle placed in a vein in the arm. They will return for UB-421 treatments every week for 26 weeks. Each visit will take 3 to 6 hours. Participants will have 2 follow-up visits 4 and 8 weeks after their last treatment with UB-421. Apheresis will be repeated at 1 of these visits.
Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose...
Pediatric HIV InfectionTuberculosis InfectionTuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV/TB cotreatment strategies in children. Current WHO-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration. Yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined in children. This study aims to evaluate the safety and pharmacokinetics of dolutegravir twice daily among HIV/TB coinfected children receiving standard-dose and high-dose rifampicin.