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

• Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease: Complete Statistical AnalysisIndependent statistical analysis of Reduced-Intensity Busulfan and Fludarabine With or Without Antithymocyte Globulin Followed by Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease: primary endpoint results, effect…Phase 2Results postedn = 71NCT00448201
• Reducing HIV Risk Among Adolescents: Evaluating Project HEART: Complete Statistical AnalysisIndependent statistical analysis of Reducing HIV Risk Among Adolescents: Evaluating Project HEART: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02579135).Phase NAResults postedn = 222NCT02579135
• Relative Bioavailability Study of Emodepside IR-tablets and Solution: Complete Statistical AnalysisIndependent statistical analysis of Relative Bioavailability Study of Emodepside IR-tablets and Solution: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03383523).Phase 1Results postedn = 77NCT03383523
• Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants: Complete Statistical AnalysisIndependent statistical analysis of Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 1Results postedn = 15NCT05525910
• Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients: Complete Statistical AnalysisIndependent statistical analysis of Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03873987).Phase 1Results postedn = 102NCT03873987
• REMAP-CAPAn independent statistical analysis of REMAP-CAP, the randomized phase 3 multifactorial adaptive platform trial evaluating multiple treatment strategies in community-acquired pneumonia, influenza, and COVID-19.Phase 3n = 20,000NCT02735707
• REMDACTAIndependent statistical analysis of the REMDACTA phase 3 trial of remdesivir plus tocilizumab versus remdesivir plus placebo in hospitalized participants with severe COVID-19 pneumonia, including time-to-event, logistic regression, and categorical endpoint results.Phase 3Results postedn = 649NCT04409262
• REMOTE-COVIDIndependent statistical analysis of Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04337489).Phase NAResults postedn = 15NCT04337489
• Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors: Complete Statistical AnalysisIndependent statistical analysis of Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 4Results postedn = 11NCT03627299
• RENOIRIndependent statistical analysis of the phase 3 RENOIR trial evaluating RSVpreF in adults with lower respiratory tract illness, including trial design, endpoints, planned statistical methods, immunogenicity, safety, and interpretation.Phase 3n = 38,861NCT05035212
• REVIRAL 1Independent statistical analysis of A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 2Results postedn = 51NCT04225897
• RIFASHORTIndependent statistical analysis of the RIFASHORT phase 3 trial evaluating 1200mg and 1800mg rifampicin for pulmonary tuberculosis, including trial design, endpoints, planned statistical methods, and interpretation.Phase 3n = 672NCT02581527
• RSV OA=ADJ-023Independent statistical analysis of A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant…Phase 2Results postedn = 386NCT05921903
• RSVHRIndependent statistical analysis of A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 2Results postedn = 187NCT05568706
• SAILINGComplete statistical analysis of the SAILING phase 3 trial comparing GSK1349572 (dolutegravir) with raltegravir in antiretroviral-experienced, integrase inhibitor-naive adults with HIV infection, including its non-inferiority design, Cochran-Mantel-Haenszel analysis, risk difference, confidence interval,…Phase 3Results postedn = 724NCT01231516
• SAR-COVIDIndependent statistical analysis of SAR-COVID (NCT04357808), a randomized phase 2 trial evaluating subcutaneous sarilumab in hospitalised patients with moderate-severe COVID-19 infection.Phase 2n = 30NCT04357808
• SCORPIO-HRComplete statistical analysis of the SCORPIO-HR phase 3 trial of S-217622 (ensitrelvir) versus placebo in non-hospitalized participants with SARS-CoV-2 infection, including trial design, time to sustained symptom resolution, restricted mean symptom duration,…Phase 3Results postedn = 2,093NCT05305547
• SEASONIndependent statistical analysis of the SEASON trial evaluating the safety, tolerability, and immunogenicity of motavizumab after dosing for a second season in children.Phase 1/2Results postedn = 136NCT00113490
• SHOCKIndependent statistical analysis of the SHOCK phase 3 trial of extracorporal cytokine removal in septic shock, covering its randomized three-arm design, shock reversal endpoints, planned time-to-event analysis, and statistical interpretation.Phase 3n = 135NCT04742764
• SINGLEComplete statistical analysis of the SINGLE phase 3 trial comparing dolutegravir plus abacavir/lamivudine with Atripla in HIV-1 infection, including the Week 48 primary endpoint, later virologic suppression analyses, CD4 outcomes, non-inferiority methodology,…Phase 3Results postedn = 844NCT01263015
• SiyakhanaIndependent statistical analysis of Community Health Worker Training to Reduce Depression and Substance Use Stigma in TB/HIV Care in South Africa: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…Phase NAResults postedn = 82NCT05282173
• SMA-TBIndependent statistical analysis of Adjunctive Acetylsalicylic Acid and Ibuprofen for Tuberculosis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04575519).Phase 2Results postedn = 426NCT04575519
• SNIFFLE-3Independent statistical analysis of Efficacy & Safety of Nasal Influenza Immunisation in Children: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02549365).Phase 4Results postedn = 276NCT02549365
• SPARTANIndependent statistical analysis of Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 4Results postedn = 132NCT01332227
• SPEEDIndependent statistical analysis of Patient Actor Training to Improve HIV Services for Adolescents in Kenya: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase NAResults postedn = 24NCT02928900
• SPIN-CHATIndependent statistical analysis of Evaluation of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together Program: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase NAResults postedn = 172NCT04335279
• SPIROMICSIndependent statistical analysis of SPIROMICS (NCT01969344), a longitudinal study of COPD subgroups, biomarkers, lung function, imaging, environmental exposures, and disease progression.n = 2,981NCT01969344
• SPRING-2Independent statistical analysis of A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 3Results postedn = 828NCT01227824
• SPRINT-2Independent statistical analysis of SPRINT-2, a randomized phase 3 trial of boceprevir plus peginterferon alfa-2b and ribavirin in previously untreated adults with chronic hepatitis C genotype 1.Phase 3Results postedn = 1,472NCT00705432
• SPRINT-SARIAn independent statistical analysis of SPRINT-SARI, a ClinicalTrials.gov study of severe acute respiratory illness focused on participating sites, data completeness, and barriers to data submission.n = 15,000NCT02498587
• STOICIndependent statistical analysis of the randomized phase 2 STOIC trial evaluating budesonide dry powder inhaler in coronavirus infection, including trial design, the primary endpoint, planned statistical analysis, and interpretation.Phase 2n = 146NCT04416399
• SUPERNOVAIndependent statistical analysis of the randomized phase 2/3 SUPERNOVA trial of AZD3152 and AZD7442 for prevention of COVID-19, including non-inferiority, superiority, Poisson regression, ANOVA, safety, and interpretation of reported results.Phase 2/3Results postedn = 3,882NCT05648110
• SWARM-PaIndependent statistical analysis of Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis: primary endpoint results, effect estimate with confidence…Phase 1/2Results postedn = 29NCT04596319
• TBTC Study 22An independent statistical analysis and educational interpretation of TBTC Study 22, a randomized phase 3 trial evaluating rifapentine and isoniazid in pulmonary tuberculosis.Phase 3n = 1,000NCT00023335
• TeenCoveComplete statistical analysis of the TeenCove trial of mRNA-1273 and mRNA-1273.222 in adolescents 12 toPhase 2/3Results postedn = 4,328NCT04649151
• TEMPRANOAn independent statistical analysis of the phase 3 TEMPRANO trial, evaluating early antiretroviral treatment and/or early isoniazid prophylaxis against tuberculosis in HIV-infected adults.Phase 3n = 2,073NCT00495651
• TH HSV REC-004Independent statistical analysis of A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years: primary endpoint results, effect estimate with…Phase 1Results postedn = 50NCT05989672
• TITREIndependent statistical analysis of Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00710866).Phase 3Results postedn = 262NCT00710866
• TOBRAIndependent statistical analysis of the randomized phase 3 TOBRA trial evaluating local vancomycin versus local vancomycin plus tobramycin powders to reduce deep surgical site infection after definitive fracture fixation.Phase 3Results postedn = 1,660NCT04597008
• TOPAZ-IIndependent statistical analysis of A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV)…Phase 3Results postedn = 1,596NCT02219490
• Torlak-300Independent statistical analysis of Phase 3 Trial of Serbian Seasonal Influenza Vaccine: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02935192).Phase 3Results postedn = 480NCT02935192
• TREAT-COVIDIndependent statistical analysis of TREAT-COVID (NCT04351516), a randomized phase 2/3 trial evaluating hydroxychloroquine versus placebo in older adults with COVID-19. Includes trial design, endpoints, planned methodology, and statistical interpretation.Phase 2/3NCT04351516
• TRISSAn independent statistical analysis of TRISS (NCT01485315), a phase 3 randomized trial evaluating transfusion requirements in septic shock, including design, endpoints, planned statistical methods, and interpretation.Phase 3n = 1,005NCT01485315
• TURQUOISE-CPBIndependent statistical analysis of A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4…Phase 3Results postedn = 36NCT02219477
• URIDxEDIndependent statistical analysis of Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02957136).Phase NAResults postedn = 194NCT02957136
• VERITASIndependent statistical analysis of Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary: primary endpoint…Phase NAResults postedn = 244NCT02636608
• VIKING-3Independent statistical analysis of the VIKING-3 phase 3 trial of dolutegravir in HIV-infected subjects with treatment failure on an integrase inhibitor-containing regimen, including endpoint definitions, reported estimates, confidence intervals, statistical methods, and…Phase 3Results postedn = 183NCT01328041
• VIOLETIndependent statistical analysis of A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 3Results postedn = 438NCT03562156
• VOICEIndependent statistical analysis of the VOICE phase 2 trial of tenofovir 1% gel, oral tenofovir disoproxil fumarate, and emtricitabine/tenofovir disoproxil fumarate for prevention of HIV infection in women.Phase 2Results postedn = 5,029NCT00705679
• VOLVERIndependent statistical analysis of Lamivudine/Dolutegravir in Virologically Suppressed Subjects With Expected or Confirmed Resistance to Lamivudine: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 2Results postedn = 167NCT04880785

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