1341. Randomized, Double-Blind, Pilot Study of Nitazoxanide (NTZ) Versus Placebo (PCB) for the Treatment of Symptoms Associated with Viral Respiratory Infection (VRI) in Children
Session: Oral Abstract Session: Respiratory Infections in Children
Saturday, October 22, 2011: 2:00 PM
Room: 156ABC
Background: VRI is a widely recognized and prevalent illness associated with multiple respiratory viruses (RV) like rhinovirus, coronavirus, influenza, parainfluenza, adenovirus and respiratory syncytial virus. Current antiviral medications have no utility beyond influenza and viral resistance has limited their utility there as well. In general, treatment options for VRIs are unsatisfactory. NTZ and its active metabolite, tizoxanide, suppress the replication of a broad range of RV in cell culture with an IC50 ranging from (0.15 - 1.5 μg/ml). The purpose of this study was to evaluate the efficacy of NTZ in reducing the duration of symptoms associated with VRI in children (1-11 yrs of age).

Methods: The study enrolled 100 children (50 NTZ/50 PCB), mean age 3.7 yrs, with suspected VRI based on clinical presentation. Patients received either: age based NTZ 100-200mg BID or PCB x 5d. In addition to the patient evaluation, a baseline nasopharyngeal swab was obtained and tested by rapid direct immunofluorescence assay (IFA) to detect RV. Patients/ parents maintained a study diary and were monitored by study personnel for 7 days. The primary endpoint was the median time from first dose to resolution of symptoms. Secondary endpoints included the presence of any illness-related physical exam abnormality at day 7; wt of daily tissue collections; proportion of patients requiring antibiotic treatment during/after study participation.

Results: The median time from first dose to resolution of VRI symptoms was 4 days for NTZ and >7 days for PCB (P<0.0001). An analysis of the secondary endpoints also favored NTZ: patients with ≥1 illness-related abnormality at day 7 (NTZ 28% v PCB 81%, P<0.0001); patients requiring antibiotics (NTZ 9% v PCB 64%, P<0.0001); mean wt of tissue collected (NTZ 6.3g v PCB 7.3g, P=0.3). RV were identified by IFA in only 17% of the study population, the small number of patients with identified RV did not allow for a subset analysis. There were no serious adverse events, or relevant differences in adverse events.

Conclusion: NTZ was safe and effective in reducing the duration of symptoms associated with VRI in children. Further studies of NTZ in the treatment of VRI are warranted, and should utilize RT-PCR and other methods to better identify possible pathogens.


Subject Category: P. Pediatric and perinatal infections

Nicolas Lopez-Chegne, MD1, Luis-Martin Julcamoro, MD2, Jean-Francois Rossignol, MD, FRCPath, PhD, FRSC3,4, Maria Carrion, MD3 and Matthew Bardin, PharmD, BCPS3, (1)Hospital Regional de Cajamarca, Cajamarca, Peru, (2)Universidad Nacional de Cajamarca, Cajamarca, Peru, (3)Romark Institute for Medical Research, Tampa, FL, (4)Department of Biochemistry, Oxford University, Glycobiology Institute, Oxford, United Kingdom

Disclosures:

N. Lopez-Chegne, Romark Laboratories: Investigator, Research support

L. M. Julcamoro, Romark Laboratories: Investigator, Research support

J. F. Rossignol, Romark Laboratories: Board Member, Employee and Shareholder, Licensing agreement or royalty and Salary

M. Carrion, Romark Laboratories: Employee, Salary

M. Bardin, Romark Laboratories: Employee, Salary

Findings in the abstracts are embargoed until 12:01 a.m. EST Thursday, Oct. 20 with the exception of research findings presented at IDSA press conferences.