Loading clinical trials...
Loading clinical trials...
Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis
To evaluate the additional effectiveness of an anti-inflammatory nasal spray ( beclomethasone dipropionate ) and a broad spectrum antibiotic ( cefuroxime axetil ) over decongestant ( Deconsal II ) alone, when these agents are given individually or in combination for the prevention of recurrent paranasal sinus infection in patients with HIV infection. To compare the clinical utility of paranasal sinus radiographs with computed tomograms (CTs) in the evaluation and management of HIV-infected patients with recurrent paranasal sinus infection. To determine relevant prognostic factors and the microbiologic etiology of maxillary sinusitis in this patient population. Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted.
Sinusitis is common among HIV-infected patients and is likely to be recurrent or refractory to traditional therapy, particularly in patients with advanced immunosuppression. An intervention aimed at prevention of recurrent sinus disease in HIV-infected patients appears to be warranted. Patients receive 21-42 days of antibiotic therapy for the defining episode of sinusitis. Following discontinuation of antibiotics, screening evaluations are performed. Within 7 days following completion of antibiotics, patients with clinical resolution begin 14 +/- 3 days of decongestant therapy with oral Deconsal II, a drug combining pseudoephedrine, a decongestant, and guaifenesin, an expectorant. Following decongestant therapy, patients undergo entry evaluations, including nasal endoscopy and sinus radiograph. Patients with continued clinical resolution and no purulence on endoscopy are then randomized to receive decongestant alone or in combination with nasal steroid (beclomethasone dipropionate) or antibiotic (cefuroxime axetil) or both. Treatment continues for a minimum of 52 weeks and a maximum of 104 weeks. Patients are followed at weeks 4, 8, and 12 and every 8 weeks thereafter.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, United States
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, United States
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, United States
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States
Completion Date
February 1, 1993
Last Updated
October 28, 2021
Pseudoephedrine hydrochloride
DRUG
Guaifenesin
DRUG
Cefuroxime axetil
DRUG
Beclomethasone dipropionate
DRUG
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
NCT06914908
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04142047