Respiratory Tract InfectionsCOMPASNCT00939185

Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections

An observational study of Respiratory Tract Infections, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study was to obtain data on the safety, tolerability and compliance with Zithromax in children with bacterial infections of the upper and lower respiratory tract. Read more about this study

Who is it for?: Ages 1 year to 14 years
Conditions the study is for: Respiratory Tract Infections
What is being tested?: Azithromycin
Type of treatment: Pill or oral medicine
How many people: 400 participants
Where: No sites listed yet
Study dates: Apr 2007to Jan 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 14 years
All sexes
No healthy volunteers
Child

Study population: ZITHROMAX® administration will be considered in children / adolescents from the first year of life up to 14 years old with the following diagnoses: Acute otitis media, Sinusitis, Pharyngitis/tonsillitis, Pneumonia, Bronchitis.

Who may be able to join

Patients with respiratory tract infections that received azithromycin according to the approved SPC as this was a non-interventional study.

Who cannot join

According to the approved Summary of Product Characteristics (SPC) for Azithromycin as this was a non interventional study.

About this study

The objective of this study was to obtain data on the safety, tolerability and compliance with Zithromax in children with bacterial infections of the upper and lower respiratory tract.

Read the detailed description

Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.

Conditions: Respiratory Tract Infections
Being tested: Azithromycin
Keywords: Compliance and Safety Study in Children with Upper and Lower Respiratory Tract Infections
Medical subject headings: Respiratory Tract Infections, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzithromycinDrug
Also called Zithromax
Zithromax was dispensed according to the Summary of Product Characteristics (SPC) as either a tablet or suspension. Zithromax was administered as a total dose of 30 mg/kg which was given as single daily doses of 10 mg/kg for 3 days, or as a 5 day dose starting with 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5.

Study groups in NCT00939185
Study group	Role	What they receive
Azithromycin group		Not described Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Adverse Events (AEs)
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.
Measured: 3 to 7 days after receiving treatment

Secondary outcomes (3)

Number of Subjects Who Withdrew From the Study
Measured: 3 to 7 days after receiving treatment
Compliance
Compliance was assessed by the following questions: Question 1: "Were the pediatrician's instructions during the treatment phase followed (i.e. dose, frequency and number of days)?"; Question 2: "Was it easy to understand your pediatrician's instructions regarding treatment?"; and Question 3: "Was the administration of this drug easier than any other previously used drug?" Patients could answer either "yes", "no", or "Not applicable (NA)".
Measured: 3 to 7 days after receiving treatment
Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital
Time of exam completion minus the start time of the examination.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Jan 2009

First posted14 Jul 2009 (estimated)
Study startApr 2007
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00939185
Sponsor's protocol ID: A0661182
Acronym: COMPAS
Status last verified: Mar 2010
First submitted: 13 Jul 2009
Last updated: 30 Mar 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Respiratory Tract Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
ClinicalTrials.gov ID: NCT00939185
Acronym / sponsor ID: COMPAS / A0661182
Conditions: Respiratory Tract Infections
Keywords: Compliance and Safety Study in Children with Upper and Lower Respiratory Tract Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 14 Jul 2009 (estimated)
Results: Posted 18 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study was to obtain data on the safety, tolerability and compliance with Zithromax in children with bacterial infections of the upper and lower respiratory tract.

Detailed description

Patients were recruited from the outpatient departments of the participating sites/hospitals/clinics.

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Azithromycin group	–	Drug: Azithromycin

Who may qualify

Ages: 1 year to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: ZITHROMAX® administration will be considered in children / adolescents from the first year of life up to 14 years old with the following diagnoses: Acute otitis media, Sinusitis, Pharyngitis/tonsillitis, Pneumonia, Bronchitis.

Key inclusion criteria (1 listed)

Patients with respiratory tract infections that received azithromycin according to the approved SPC as this was a non-interventional study.

Key exclusion criteria (1 listed)

According to the approved Summary of Product Characteristics (SPC) for Azithromycin as this was a non interventional study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AzithromycinAlso: ZithromaxZithromax was dispensed according to the Summary of Product Characteristics (SPC) as either a tablet or suspension. Zithromax was administered as a total dose of 30 mg/kg which was given as single daily doses of 10 mg/kg for 3 days, or as a 5 day dose starting with 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5.	Drug	Azithromycin group

Primary outcome

Number of Patients With Adverse Events (AEs)
Time frame: 3 to 7 days after receiving treatment
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product(s) were reported.

3 secondary outcomes

Number of Subjects Who Withdrew From the Study
Time frame: 3 to 7 days after receiving treatment
Compliance
Time frame: 3 to 7 days after receiving treatment
Time Reported for a Patient Being Consulted and Diagnosed From the Moment He/She Entered the Hospital
Time frame: Day 1

Results and safety

Results posted to the registry on 18 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azithromycin	400	375

Primary outcome: Number of Patients With Adverse Events (AEs)

Time frame: 3 to 7 days after receiving treatment. Number. Unit: participants

Measure	Azithromycin n = 390
Value	27

Population analysed: Safety population = Those subjects who were known to have received at least one dose of the study treatment. Subjects who were dispensed study treatment and immediately lost to follow-up were not included among those known to have been dosed.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azithromycin	0 of 390 (0%)	27 of 390 (6.9%)	Not reported

Limitations and caveats (from the sponsor): Only 1 subject received tablet; therefore, no suspension versus tablet efficacy data is displayed as initially planned.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Respiratory Tract Infections

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Tract Infections, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Adverse Events (AEs) (time frame: 3 to 7 days after receiving treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00939185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2010.