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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 May 10, 2018

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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.
Show details

- 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.
Show details

- 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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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
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
The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with Acute Maxillary Sinusitis
Maxillary Sinusitis
  • Drug: Azithromycin SR
    Azithromycin SR, 2.0 g by mouth (PO) x 1
  • Drug: Amoxiclav 1000 mg
    Amoxiclav 1000 mg x twice daily, 10 days
  • Azithromycin SR
    Acute Bacterial Maxillary Sinusitis
    Intervention: Drug: Azithromycin SR
  • Amoxiclav 1000 mg
    Acute Bacterial Maxillary Sinusitis
    Intervention: Drug: Amoxiclav 1000 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
March 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01032174
A0661199
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2012

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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