RANDOMIZED, DOUBLE-BLIND, MULTICENTRIC COMPARATIVE STUDY, PHASE III, WITH TWO COURSES OF DIFFERENT THERAPY WITH BMS-284756 ORAL VS AMOXICILLINE / ORAL CLAVULANATE IN THE TREATMENT OF ACUTE SINUSITIS
- Conditions
- -J01J01
- Registration Number
- PER-054-01
- Lead Sponsor
- BRISTOL MYERS SQUIBB PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Men or women of eighteen years of age or older, in whom oral therapy is indicated;
• Subjects with clinical signs and symptoms consistent with acute maxillary sinus infection, proven by:
1) Pain and / or facial hypersensitivity in one or both maxillary areas (the duration of the signs and symptoms of sinusitis is more than 7 days and less than 28 days),
2) Two or more of the following signs / symptoms / laboratory findings:
(a) Fever (oral temperature> 38 ° C or> 100.4 ° F, tympanic temperature> 38.5 ° C or> I01.2 ° F, or rectal temperature> 39 ° C or> 102.2 = F),
(b) Leukocytosis (> 10,000 leukocytes / mm or> 15% band forms),
(c) Nasal congestion,
(d) Postnasal drainage,
(e) Frequent cough,
(f) Headache.
3) At least one of the following findings on the physical examination.
(a) Purulent discharge from the maxillary sinus orifice, or
(b) Purulent discharge from the nose, or
(c) Purulent drainage in the posterior pharynx.
• The informed consent of the subject or his legally authorized representative must be obtained
• Women of childbearing age (MEF) must have a serum or urine pregnancy test with a negative result (minimum sensitivity 25 IU / L or its equivalent in units of HCG) obtained in the 48 prior to the start of the administration of the drug of the study.
• Subjects presenting with a current episode of sinusitis with symptoms for more than 28 days;
• Three or more episodes of acute sinusitis in the previous six months,
• Complicated sinusitis (eg, Pott´s swollen tumor, malignancy affecting the breast, osteomyelitis, infection of the contiguous bone, or need for reconstructive surgery);
• Anatomical abnormality that involves the ostium of the maxillary sinus and that would damage the sinus drainage, being able to affect the response to the therapy (for example, post-traumatic or post-surgical defect);
• Recent surgery of the nose or sinuses (that is, in the 3 months prior to admission);
• Nosocomial sinusitis secondary to head trauma or nasotracheal intubation;
• Have received more than a single dose of any therapy with systemic antibiotics in the 7 days prior to admission, or probability of receiving other systemic antibiotics during their participation in the study;
• Subjects who, in the opinion of the Investigator, may require long-term antibacterial therapy (for more than 10 days);
• Subjects with cystic fibrosis;
• Current known and clinically significant liver disease, or known levels of ALT and / or AST and / or total bilirubin times the normal maximum limit;
• Known renal insufficiency (eg, serum creatinine> 2.0 mg / dL [176.7 pmol / L] or requiring renal dialysis);
• History of serious hypersensitivity reaction (eg, urticaria, anaphylaxis) to any quinolone or beta-lactam compound,
• Subjects with previous diagnosis of immune system disease (s) (eg, AIDS, current neutrophil count <1000 / mm ^);
• Malabsorption syndromes or other gastrointestinal disorders that affect the absorption of the medication;
• Use of a research agent concomitantly or within 30 days, immediately prior to admission in this study;
• Pregnancy and / or lactation;
• Fertile women who are not using an adequate birth control method,
• Have been previously admitted to any study with BMS-284756;
• Presence of any disorder or disease that may interfere with the evaluation of the study medication and / or due to which, in the opinion of the investigator, it would not be appropriate to admit the subject in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical evaluation<br>Measure:Clinical cure rates with BMS-284756 (5 days or 10 days) and amoxicillin / clavulanate (10 days)<br>Timepoints:In the visit made after the treatment (Visit of the Healing Test)<br>
- Secondary Outcome Measures
Name Time Method