Infectious Disease Clinical Trials

Statistical methods in infectious disease trials

The methods these trials rely on most, based on the statistical analyses posted to ClinicalTrials.gov, with the tutorial that explains each one.

All infectious disease trials

903 results

• INROADSIndependent statistical analysis of A Study of the Once Daily Combination of Etravirine and Darunavir/Ritonavir As Dual Therapy in Early Treatment-Experienced Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 54NCT01199939
• INSIGHTIndependent statistical analysis of A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 2Results postedn = 24NCT04585789
• INSPIREIndependent statistical analysis of Alcohol Pharmacotherapy for HIV+ Prisoners: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01077310).Phase NAResults postedn = 100NCT01077310
• InTSHAIndependent statistical analysis of InTSHA: Interactive Transition Support for HIV-infected Adolescents Using Social Media: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03624413).Phase NAResults postedn = 80NCT03624413
• INVESTIndependent statistical analysis of Increasing Vaccine Uptake Among Adolescents in the Rural South: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04999267).Phase NAResults postedn = 2NCT04999267
• Iota-Carrageenan Nasal Spray in Common Cold: Complete Statistical AnalysisIndependent statistical analysis of Iota-Carrageenan Nasal Spray in Common Cold: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01944631).Phase 4Results postedn = 200NCT01944631
• IPERGAYIndependent statistical analysis of IPERGAY, a phase 3 randomized trial evaluating on-demand antiretroviral pre-exposure prophylaxis for HIV infection prevention in men who have sex with men.Phase 3n = 400NCT01473472
• Ipilimumab and Local Radiation for Selected Solid Tumors: Complete Statistical AnalysisIndependent statistical analysis of Ipilimumab and Local Radiation for Selected Solid Tumors: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01769222).Phase 1Results postedn = 3NCT01769222
• Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections: Complete Statistical AnalysisIndependent statistical analysis of Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase NAResults postedn = 627NCT02255487
• iTransition Development: Complete Statistical AnalysisIndependent statistical analysis of iTransition Development: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04383223).Phase NAResults postedn = 78NCT04383223
• JUNGLEIndependent statistical analysis of Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase NAResults postedn = 209NCT03518060
• KALMARIndependent statistical analysis of Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01068873).Phase 4Results postedn = 1NCT01068873
• Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS: Complete Statistical AnalysisIndependent statistical analysis of Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase NAResults postedn = 73NCT02276066
• KIU!Independent statistical analysis of Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men: primary endpoint results, effect estimate with confidence interval,…Phase NAResults postedn = 901NCT01836445
• Laparoscopic Versus Open Appendectomy? Let the Patient Decide: Complete Statistical AnalysisIndependent statistical analysis of Laparoscopic Versus Open Appendectomy? Let the Patient Decide: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01738750).Phase NAResults postedn = 100NCT01738750
• LATTEAn independent statistical analysis of the phase 2 LATTE study of long-acting cabotegravir plus long-acting rilpivirine administered every 2 months in HIV-positive participants.Phase 2Results postedn = 97NCT03639311
• Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease: Complete Statistical AnalysisIndependent statistical analysis of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease: primary endpoint results, effect estimate with confidence interval,…Phase 2Results postedn = 10NCT02301936
• Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection: Complete Statistical AnalysisIndependent statistical analysis of Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 2Results postedn = 40NCT02219685
• Less Infections for the Diabetic Foot: Complete Statistical AnalysisIndependent statistical analysis of Less Infections for the Diabetic Foot: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03615807).Phase NAResults postedn = 182NCT03615807
• Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001): Complete Statistical AnalysisIndependent statistical analysis of Letermovir (MK-8228) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001): primary endpoint results, effect estimate with…Phase 3Results postedn = 570NCT02137772
• LIDIndependent statistical analysis of Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age: primary…Phase 1Results postedn = 17NCT02890381
• Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care: Complete Statistical AnalysisIndependent statistical analysis of Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04316715).Phase NAResults postedn = 300NCT04316715
• Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria: Complete Statistical AnalysisIndependent statistical analysis of Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01315236).Phase 2Results postedn = 90NCT01315236
• LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients: Complete Statistical AnalysisIndependent statistical analysis of LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 4Results postedn = 32NCT02631772
• Living Well Project for Persons With AIDS: Complete Statistical AnalysisIndependent statistical analysis of Living Well Project for Persons With AIDS: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01848483).Phase NAResults postedn = 121NCT01848483
• Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg): Complete Statistical AnalysisIndependent statistical analysis of Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen…Phase 4Results postedn = 36NCT00240539
• Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study: Complete Statistical AnalysisIndependent statistical analysis of Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study: primary endpoint results, effect estimate…Phase 3Results postedn = 23NCT01246479
• Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine: Complete Statistical AnalysisIndependent statistical analysis of Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 1,737NCT00323622
• Long-Term Immune Persistence of GSK Biologicals’ Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule: Complete Statistical AnalysisIndependent statistical analysis of Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 3Results postedn = 51NCT00289718
• Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals’ Hepatitis B Vaccine (HBV), Engerix-B: Complete Statistical AnalysisIndependent statistical analysis of Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 4Results postedn = 106NCT02901951
• Longitudinal Study of Dental Implant Therapy in HIV Positive Patients: Complete Statistical AnalysisIndependent statistical analysis of Longitudinal Study of Dental Implant Therapy in HIV Positive Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01211288).Phase NAResults postedn = 41NCT01211288
• Lopinavir/Ritonavir (Kaletra) PK in Children: Complete Statistical AnalysisIndependent statistical analysis of Lopinavir/Ritonavir (Kaletra) PK in Children: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00810108).Phase 4Results postedn = 12NCT00810108
• LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial): Complete Statistical AnalysisIndependent statistical analysis of LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05780268).Phase 3Results postedn = 314NCT05780268
• LYNXIndependent statistical analysis of A Comparison of Body Fat Distribution in HIV-1 Infected Patients Receiving, Since the Beginning and for at Least Two Years, an Antiretroviral Therapy Based on Efavirenz or Lopinavir/Ritonavir…Phase NAResults postedn = 346NCT01159743
• Lyophilized IMVAMUNE® (1×10^8 TCID50) Versus Liquid IMVAMUNE® (1×10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2×10^7 TCID50) Administered Intradermally: Complete Statistical AnalysisIndependent statistical analysis of Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally: primary endpoint results, effect estimate with confidence…Phase 2Results postedn = 523NCT00914732
• M032-HSV-1Independent statistical analysis of Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 1Results postedn = 29NCT02062827
• MA181Independent statistical analysis of Assessing Choice in the Employer Setting (ACES) Study: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00808808).Phase NAResults postedn = 4,411NCT00808808
• MACH19Independent statistical analysis of RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase NAResults postedn = 90NCT04951336
• Macrophage Phagocytosis in COPD: Complete Statistical AnalysisIndependent statistical analysis of Macrophage Phagocytosis in COPD: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00298389).Phase NAResults postedn = 56NCT00298389
• MAGELLAN-3Independent statistical analysis of Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in…Phase 3Results postedn = 33NCT02939989
• Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage: Complete Statistical AnalysisIndependent statistical analysis of Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 3Results postedn = 23NCT00691600
• MAVERICIndependent statistical analysis of Maraviroc Efficacy for Hepatitis C: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02881762).Phase 4Results postedn = 10NCT02881762
• Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation: Complete Statistical AnalysisIndependent statistical analysis of Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 2Results postedn = 40NCT04399980
• MCAPIndependent statistical analysis of HIV Prevention Toolkit for HIV-negative Male Couples: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02494817).Phase NAResults postedn = 298NCT02494817
• MDP 301Independent statistical analysis and educational interpretation of the randomized phase 3 MDP 301 trial evaluating PRO 2000/5 gel for prevention of vaginally acquired HIV infection, including trial design, endpoints, planned statistical methods,…Phase 3n = 9,404NCT00262106
• Mechanisms of Lipodystrophy in HIV-Infected Pateints: Complete Statistical AnalysisIndependent statistical analysis of Mechanisms of Lipodystrophy in HIV-Infected Pateints: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00457665).Phase 4Results postedn = 56NCT00457665
• MEDI8897 Ph2bComplete statistical analysis of the randomized phase 2 MEDI8897 Ph2b trial evaluating MEDI8897 for prevention of medically attended RSV lower respiratory tract infection in healthy preterm infants.Phase 2Results postedn = 1,453NCT02878330
• Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men: Complete Statistical AnalysisIndependent statistical analysis of Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase NAResults postedn = 1,181NCT01490359
• Mesalamine to Reduce T Cell Activation in HIV Infection: Complete Statistical AnalysisIndependent statistical analysis of Mesalamine to Reduce T Cell Activation in HIV Infection: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01090102).Phase 4Results postedn = 33NCT01090102
• Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer: Complete Statistical AnalysisIndependent statistical analysis of Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase NAResults postedn = 1NCT00726830

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