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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 November 16, 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.
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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Descriptive Information
Brief TitleNon-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
Official TitleNon-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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with Acute Maxillary Sinusitis
ConditionMaxillary Sinusitis
Intervention
  • 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
Study Groups/Cohorts
  • Azithromycin SR
    Acute Bacterial Maxillary Sinusitis
    Intervention: Drug: Azithromycin SR
  • Amoxiclav 1000 mg
    Acute Bacterial Maxillary Sinusitis
    Intervention: Drug: Amoxiclav 1000 mg
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: June 9, 2011)
123
Original Estimated Enrollment
 (submitted: December 14, 2009)
120
Actual Study Completion DateMarch 2011
Actual Primary Completion DateMarch 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01032174
Other Study ID NumbersA0661199
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2012

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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