Clinical Trials Logo

Clinical Trial Summary

The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.


Clinical Trial Description

The proposed study will be a randomized, double-blinded, placebo-controlled Phase III trial to examine the efficacy of AZM therapy relative to placebo in reducing RSV-related morbidity. Patients will be recruited during acute hospitalization and admission to the ICU at 5 pediatric hospitals. The target population selected is pediatric patients with severe RSV lung disease as defined by need for ICU management and intensive respiratory support. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05026749
Study type Interventional
Source University of Alabama at Birmingham
Contact Michele Kong, MD
Phone 205-638-9387
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date December 31, 2021
Completion date December 31, 2028

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03698084 - RESCEU: Defining the Burden of RSV Disease
Completed NCT04090658 - A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults Phase 1
Recruiting NCT04231968 - A Study of AK0529 in Chinese Infants Hospitalized With RSV Phase 3
Completed NCT03227029 - Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age Phase 1
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
Withdrawn NCT02864628 - RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults. Phase 1
Terminated NCT02948127 - Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants and Children 6 to 24 Months of Age Phase 1
Completed NCT02873286 - RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults Phase 2
Completed NCT02237209 - Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1
Completed NCT02247726 - RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women. Phase 2
Completed NCT02040831 - Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1
Completed NCT01915394 - Respiratory Syncytial Virus Infection in Neonatal Intensive Care Units Throughout Turkey: Prospective Multicenter Study (TurkNICU-RSV Trial) N/A
Completed NCT01355016 - A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers Phase 1
Completed NCT00232635 - A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT Phase 2
Not yet recruiting NCT05045144 - A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women. Phase 3
Completed NCT01155193 - Prospective Study for the Use of Palivizumab (Synagis®) in High-risk Children in Germany
Terminated NCT02890381 - 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 Phase 1
Active, not recruiting NCT03422237 - Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 6 to 24 Months of Age Phase 1
Completed NCT03674177 - A Study to Evaluate Different Dose Levels of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3888550A), Based on the Vaccine Safety and the Antibodies (Body Defences) Produced Following Vaccine Administration, When Given to Healthy Non-pregnant Women Phase 1
Completed NCT01968083 - Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children Phase 1