Phase 4 N=56 Canadian Hemophilia Prophylaxis Study
Severe Hemophilia A
Primary: Number of Participants Who Developed Target Joint Bleeding — 17 Participants
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N/A N=241 Vfend Special Investigation For Prophylaxis
Fungal Infection
Primary: Number of Participants With Adverse Drug Reactions — 62; 5 Participants
Phase 4 N=30 Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Hemophilia A
Primary: Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period — 56.00 Bleeds
Phase 4 N=51 Oral Vancomyin for Primary Clostridium Difficile Infection Prophylaxis in Patients Receiving High-Risk Antibiotics
Clostridium Difficile Infection · Prophylaxis · Vancomycin
Primary: Clostridium Difficile Infection Occurrence — 2; 0 Participants
Phase 2 N=536 The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP)
HIV Infections
Primary: Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing — 75; 56; 52; 85 percentage of sexual exposures
Phase 4 N=581 Chemoprophylaxis Plus Early Ambulation
Pulmonary Embolism · Thoracic Surgery
Primary: Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies. — 3 Participants
Phase 3 N=1,483 Pre-exposure Prophylaxis for SARS-Coronavirus-2
COVID-19 · Corona Virus Infection · ARDS
Primary: COVID-19-free Survival — 464; 468; 454 Participants
N/A N=86 PROPACT: Retrospective Prophylaxis Patient Case Collection
Congenital Bleeding Disorder · Haemophilia A With Inhibitors · Haemophilia B With Inhibitors
Primary: Percent Change in Total Bleed Episodes Per Month - Bleeding Population — -45 percent change (%) in bleeds per month
Phase 4 N=45 Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
Prophylaxis Of Invasive Fungal Infections
Primary: Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit — 3 participants
Phase 2 N=267 Interventions for HIV Negative Men and Women Who Have High-risk Suspected Exposure to HIV
HIV Prevention · HIV Infections
Primary: Retention, Measured as the Number of HIV Exposure Events That Were Retained in Care at the 24 Week Follow-up Visit — 125; 157 HIV Exposure Events — p=<0.05
Phase 2 N=90 Continuous Antibiotic Prophylaxis in Colorectal Surgery
Surgical Site Infection
Primary: Number of Patients With a Surgical Site Infection — 10; 13 Participants
N/A N=219 Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction
Ureteral Obstruction · Neoplasms · Acute Kidney Injury
Primary: Urinary Tract Infection After Percutaneous Nephrostomy Procedure — 5; 10 Percutaneous nephrostomy procedure — p=0.548
Phase 4 N=756 Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries
Postpartum Sepsis · Postpartum Endometritis · Postpartum Fever
Primary: Number of Participants Who Experienced Composite Peripartum Infection or Death — 15; 17; 24 Participants
Phase 2 N=79 Efficacy of Oral Vancomycin Prophylaxis for Prevention of Recurrent Clostridium Difficile Infection
Recurrent Clostridium Difficile Infection · Clostridium Difficile Infection · CDI
Primary: Recurrent Clostridium Difficile Infection (CDI) — 17; 24 Participants — p=0.22
Phase 4 N=73 Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
Hemophilia A
Primary: Mean Transformed Annualized Bleed Rate Estimates From Each of the 1-year Prophylaxis Regimens — 1.61; 1.46 (bleeds/year)^(1/2) — p=0.6016
N/A N=1,499 Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi
HIV
Primary: Severe Events — 3.3; 4.2; 4.2 Events per 100 participant-years — p=<=0.05
Phase 3 N=4,758 Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples
HIV-1 Infections · HIV Infections
Primary: Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants — 0.65; 0.50; 1.99 events per 100 person years — p=<0.001
Phase 4 N=205 CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")
Cytomegalovirus Infection
Primary: Incidence of Cytomegalovirus (CMV) Disease. — 9; 20 participants — p=0.0396
N/A N=251 Efficacy of Post-operative Antibiotic Prophylaxis for Thoracic Surgery Requiring Tube Thoracostomy
Antibiotic Prophylaxis
Primary: Number of Participants Who Experienced At Least One Postoperative Infectious Complication — 13; 8 Participants — p=.26
N/A N=400 Timing of Antibiotic Prophylaxis for Cesarean Deliveries
Infection
Primary: Endometritis and Wound Infection — 6; 4 patients infected
Phase 3 N=1,219 Botswana TDF/FTC Oral HIV Prophylaxis Trial
HIV Infections
Primary: Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms — 91.2; 88.2 percentage of participants with AE — p=0.003
N/A N=318 Pre-exposure Prophylaxis (PrEP) at Home
HIV/AIDS
Primary: Number of Participants Achieving Appropriate Levels of Tenofovir-diphosphate (TFV-DP) at 6-month Follow-up — 78; 39 Participants
Phase 3 N=5,197 Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult.
COVID-19
Primary: Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness — 8; 17; 12; 34 Participants — p=<0.001
N/A N=1,175 Toronto Thromboprophylaxis Patient Safety Initiative
Venous Thromboembolism
Primary: Percentage of Patients Prescribed Appropriate VTE Prophylaxis — 64; 62; 67; 54 percentage of patients
N/A N=171,705 Prophylactic Efficacy of Relenza Against Influenza A and B
Pulmonary Disease, Chronic Obstructive · Bronchospasm · Influenza, Human
Primary: Number of Patients With Influenza — 3; 10; 2539; 93 patients
Phase 1 N=22 DSM265 Chemoprophylaxis of Plasmodium Falciparum Malaria
Plasmodium Falciparum, Malaria
Primary: Infection Rate — 5; 6; 3; 0 Participants
Phase 4 N=20 BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
Hematologic Disease · Hemophilia A
Primary: Number of Joint Bleeds — 18.5; 1.5 Number of joint bleeds — p=<0.001
Phase 2 N=14 Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A
Hemophilia A
Primary: Hemophilia Joint Health Score (HJHS) 2.0 — 3.77 score on a scale
Phase 2 N=308 A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV
HIV · Pregnancy Malaria · Sexually Transmitted Infection
Primary: Plasmodium Falciparum Peripheral Parasitemia — 8; 7 Participants
Phase 3 N=58,747 Azithromycin-Prevention in Labor Use Study (A-PLUS)
Maternal Death · Maternal Infections Affecting Fetus or Newborn · Neonatal SEPSIS
Primary: Maternal Death or Sepsis Within 6 Weeks (42 Days) Post-delivery in Intervention vs. Placebo Group. — 227; 344 Participants — p=<0.001