Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000752
Status:
WITHDRAWN
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
Preventing Frequent Sinus Infections in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis Role of Anti-Inflammatory Antibacterial and Decongestant Prophylaxis
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: