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Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Maxillary Sinusitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or nor pregnant or lactating female outpatients, 18 years of age or older.

- A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as
demonstrated by presence of the following signs and symptoms for a minimum duration of
7-10 days:

1. Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or
pain in one or both maxillary areas that worsens with movement or percussion, and

2. Presence of one or more of the following signs:

i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent
discharge from the maxillary sinus orifice

- A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis.
At least one of the following must be documented in one or both maxillary sinuses on
radiologic examination:

1. complete or partial opacification

2. an air/fluid level

Two or more of the following:

1. fever, as defined by temperature: >38ºC

2. leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR;

3. headache,

4. nasal congestion and post nasal drainage.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Known or suspected hypersensitivity or intolerance or contraindications to
Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.

NCT01032174
Pfizer
Completed
Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis

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