Respiratory viral infections are major causes of severe acute respiratory illness (SARI) and can lead to severe outcomes including hospitalization. This study evaluated the safety, effectiveness, and tolerability of nitazoxanide (NTZ), in combination with standard of care, in treating SARI in people who were hospitalized. This study started on February 2014 and was completed on January 2018 with an enrollment of 260 participants. It was concluded that treatment with nitazoxanide did not reduce the duration of hospital stay in severe influenza-like illness. Further analyses based on age and evaluations by virus did not reveal any subgroups that appeared to benefit from nitazoxanide.
A Randomized Double-Blind Phase 2 Study Comparing the Efficacy, Safety, and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications
The objective of this study was to assess the efficacy, safety, and tolerability of combination antivirals (amantadine/ribavirin/oseltamivir) versus oseltamivir alone for the treatment of influenza in an at-risk population. This study enrolled 881 participants worldwide, which were randomly selected in a 1:1 ratio to receive a blinded study treatment consisting of either the combination of amantadine, oseltamivir, and ribavirin or oseltamivir alone for 5 days. This study started on September 2010 and ended on March 2017. One of the outcomes was that combination treatment showed a significant decrease in viral shedding at day 3 relative to monotherapy, this difference was not associated with improved clinical benefit.
Presence of Respiratory Viruses in Subjects without ILI Symptoms (Healthy Cohort)
This study evaluated subjects without Influenza Like Illness (ILI) symptoms for the presence of respiratory viruses and allowed comparison to the ILI 002 study population over a period of 28 days. This observational substudy started on November 2013 and was completed on May 2014 with an enrollment of 157 participants. The results showed multiple respiratory viruses beyond influenza are associated with significant morbidity and mortality among adults and children in Mexico City. Detection of these agents could be useful for the adjustment of antibiotic treatment in severe cases.
The Evaluation of Potential Zika, Chikungunya, and Dengue Infections in Mexico (Zik01)
This natural history study sought to estimate the proportion of subjects who had confirmed Zika, Chikungunya, or Dengue virus (including co-infections) from subjects who presented fever and/or rash in southeastern Mexico. The study also compared the clinical signs, symptoms, and laboratory abnormalities associated with acute Zika, Chikungunya, and Dengue infection. The Zik01 study started on June 2016 and was completed on January 2019 with an enrollment of 600 participants.
Short Period Incidence Study of Severe Acute Respiratory Infection (SPRINT-SARI)
SPRINT-SARI is an observational, multi-center, prospective, international study of the incidence in a short period of patients with Severe Acute Respiratory Infection (SARI) in participating hospitals and intensive care units (ICUs) worldwide. It is performed in winter in both hemispheres for a period of 5 to 7 days, enrolling patients who meet the SARI case definition who have recently been admitted to the hospitals / ICUs of the participating sites. It is intended to characterize patients with SARI as a global problem to improve information in management strategies and ultimately improve the ability of health care systems to respond quickly to emerging SARI-causing infections. The 2019 season took place from February 11 to 18 with a enrollment of 19 participants.
Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (FLU-IVIG)
FLU-IVIG was a randomized, double blind, placebo-controlled, multicenter, international clinical trial that sought to determine if when intravenous hyperimmune immunoglobulin (IVIG) was added to standard of care (SOC) treatment for individuals with influenza A or B, administration of IVIG was superior to placebo in terms of reducing disease severity and duration. This study started in Mexico on March 08, 2018 and closed on June 01, 2018 with an enrollment of 3 participants.