Respiratory Tract InfectionsKLARAINENCT01095978

Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine

An observational study of Respiratory Tract Infections, run by Abbott at 126 sites in Ukraine.

Completed

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

Trial summary

To describe the relief of symptoms, tolerability, and compliance of treatment with Klacid® sustained release (SR) at a dose of 1000 mg once daily in patients with acute tracheitis, acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic bronchitis or mild community-acquired… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Tract Infections
What is being tested?: Clarithromycin (Klacid SR)
How many people: 2,822 participants
Where: 126 sitesUkraine
Study dates: Aug 2009to May 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Consulting rooms of general practitioners, pulmonologists, and allergologists and centers with experience in the treatment of patients with acute upper respiratory tract diseases, acute bronchitis or acute exacerbation of chronic bronchitis or mild community-acquired pneumonia.

Who may be able to join

Men, women 18 years with
Acute tracheitis.
Acute tracheobronchitis.
Acute bronchitis.
Mild community-acquired pneumonia.
Acute exacerbation of chronic bronchitis.
To whom decision to initiate Klacid SR therapy in a dose of 1000 mg has been made by physician.

Who cannot join

Known hypersensitivity to macrolide antibiotics
Documented renal impairment (creatinine clearance under 30 ml/min)
Concomitant therapy with the following drugs: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine
Pregnancy
Breast feeding

Trial locations and contacts

126 sites in 1 country.

City, postcode or hospital

126 sites in 1 country

Ukraine126 sites

Site Reference ID/Investigator# 29842
Dnipro, 49000
Site Reference ID/Investigator# 29848
Dnipro, 49000
Site Reference ID/Investigator# 30028
Dnipro, 49000
Site Reference ID/Investigator# 30046
Dnipro, 49000
Site Reference ID/Investigator# 30047
Dnipro, 49000
Site Reference ID/Investigator# 30049
Dnipro, 49000
Site Reference ID/Investigator# 30059
Dnipro, 49000
Site Reference ID/Investigator# 30074
Dnipro, 49000
Site Reference ID/Investigator# 30080
Dnipro, 49000
Site Reference ID/Investigator# 30099
Dnipro, 49000
Site Reference ID/Investigator# 30535
Dnipro, 49000
Site Reference ID/Investigator# 30572
Dnipro, 49000
Site Reference ID/Investigator# 30574
Dnipro, 49000
Site Reference ID/Investigator# 30575
Dnipro, 49000
Site Reference ID/Investigator# 30576
Dnipro, 49000
Site Reference ID/Investigator# 30577
Dnipro, 49000
Site Reference ID/Investigator# 30578
Dnipro, 49000
Site Reference ID/Investigator# 30579
Dnipro, 49000
Site Reference ID/Investigator# 30580
Dnipro, 49000
Site Reference ID/Investigator# 30581
Dnipro, 49000
Site Reference ID/Investigator# 30582
Dnipro, 49000
Site Reference ID/Investigator# 30583
Dnipro, 49000
Site Reference ID/Investigator# 30589
Dnipro, 49000
Site Reference ID/Investigator# 30590
Dnipro, 49000
Site Reference ID/Investigator# 30622
Dnipro, 49000
Site Reference ID/Investigator# 30623
Dnipro, 49000
Site Reference ID/Investigator# 30050
Donetsk, 83000
Site Reference ID/Investigator# 30051
Donetsk, 83000
Site Reference ID/Investigator# 30054
Donetsk, 83000
Site Reference ID/Investigator# 30057
Donetsk, 83000
Site Reference ID/Investigator# 30060
Donetsk, 83000
Site Reference ID/Investigator# 30066
Donetsk, 83000
Site Reference ID/Investigator# 30071
Donetsk, 83000
Site Reference ID/Investigator# 30073
Donetsk, 83000
Site Reference ID/Investigator# 30573
Donetsk, 83000
Site Reference ID/Investigator# 30584
Donetsk, 83000
Site Reference ID/Investigator# 30585
Donetsk, 83000
Site Reference ID/Investigator# 30600
Donetsk, 83000
Site Reference ID/Investigator# 30601
Donetsk, 83000
Site Reference ID/Investigator# 30586
Donetsk, 83112
Site Reference ID/Investigator# 30587
Donetsk, 83112
Site Reference ID/Investigator# 30588
Donetsk, 83112
Site Reference ID/Investigator# 29840
Kharkiv, 61000
Site Reference ID/Investigator# 30052
Kharkiv, 61000
Site Reference ID/Investigator# 30056
Kharkiv, 61000
Site Reference ID/Investigator# 30058
Kharkiv, 61000
Site Reference ID/Investigator# 30065
Kharkiv, 61000
Site Reference ID/Investigator# 30067
Kharkiv, 61000
Site Reference ID/Investigator# 30075
Kharkiv, 61000
Site Reference ID/Investigator# 30076
Kharkiv, 61000
Site Reference ID/Investigator# 30078
Kharkiv, 61000
Site Reference ID/Investigator# 30079
Kharkiv, 61000
Site Reference ID/Investigator# 30096
Kharkiv, 61000
Site Reference ID/Investigator# 30102
Kharkiv, 61000
Site Reference ID/Investigator# 30616
Kharkiv, 61000
Site Reference ID/Investigator# 30617
Kharkiv, 61000
Site Reference ID/Investigator# 30624
Kharkiv, 61000
Site Reference ID/Investigator# 30625
Kharkiv, 61000
Site Reference ID/Investigator# 30626
Kharkiv, 61000
Site Reference ID/Investigator# 30627
Kharkiv, 61000
Site Reference ID/Investigator# 30628
Kharkiv, 61000
Site Reference ID/Investigator# 30632
Kharkiv, 61000
Site Reference ID/Investigator# 30633
Kharkiv, 61000
Site Reference ID/Investigator# 40761
Kharkiv, 61000
Site Reference ID/Investigator# 30027
Kiev, 01000
Site Reference ID/Investigator# 30097
Kiev, 01004
Site Reference ID/Investigator# 30098
Kiev, 01004
Site Reference ID/Investigator# 30100
Kiev, 01004
Site Reference ID/Investigator# 30614
Kiev, 01004
Site Reference ID/Investigator# 30615
Kiev, 01004
Site Reference ID/Investigator# 30101
Kiev, 01030
Site Reference ID/Investigator# 22142
Kiev, 01033
Site Reference ID/Investigator# 30553
Kiev, 01033
Site Reference ID/Investigator# 30554
Kiev, 01033
Site Reference ID/Investigator# 30555
Kiev, 01033
Site Reference ID/Investigator# 30556
Kiev, 01033
Site Reference ID/Investigator# 30557
Kiev, 01033
Site Reference ID/Investigator# 30558
Kiev, 01033
Site Reference ID/Investigator# 30061
Kiev, 02094
Site Reference ID/Investigator# 30533
Kiev, 03026
Site Reference ID/Investigator# 30534
Kiev, 03026
Site Reference ID/Investigator# 30591
Kiev, 03110
Site Reference ID/Investigator# 30592
Kiev, 03110
Site Reference ID/Investigator# 30593
Kiev, 03110
Site Reference ID/Investigator# 30069
Kiev, 03115
Site Reference ID/Investigator# 30537
Kiev, 04053
Site Reference ID/Investigator# 30538
Kiev, 04053
Site Reference ID/Investigator# 30539
Kiev, 04053
Site Reference ID/Investigator# 30540
Kiev, 04053
Site Reference ID/Investigator# 29839
Kiev, 04074
Site Reference ID/Investigator# 30531
Kremenchuk, 39600
Site Reference ID/Investigator# 30532
Kremenchuk, 39600
Site Reference ID/Investigator# 40759
Kyiv, 22666
Site Reference ID/Investigator# 40760
Kyiv, 22666
Site Reference ID/Investigator# 30604
Luhansk, 91000
Site Reference ID/Investigator# 30605
Luhansk, 91000
Site Reference ID/Investigator# 30606
Luhansk, 91000
Site Reference ID/Investigator# 30559
Lviv, 79000
Site Reference ID/Investigator# 30561
Lviv, 79000
Site Reference ID/Investigator# 30562
Lviv, 79000
Site Reference ID/Investigator# 30563
Lviv, 79000
Site Reference ID/Investigator# 30564
Lviv, 79000
Site Reference ID/Investigator# 29948
Odesa, 65000
Site Reference ID/Investigator# 30055
Odesa, 65000
Site Reference ID/Investigator# 30062
Odesa, 65000
Site Reference ID/Investigator# 30594
Odesa, 65000
Site Reference ID/Investigator# 30595
Odesa, 65000
Site Reference ID/Investigator# 29838
Poltava, 36000
Site Reference ID/Investigator# 30044
Poltava, 36000
Site Reference ID/Investigator# 30045
Poltava, 36000
Site Reference ID/Investigator# 30063
Poltava, 36000
Site Reference ID/Investigator# 30126
Poltava, 36000
Site Reference ID/Investigator# 30618
Poltava, 36000
Site Reference ID/Investigator# 30619
Poltava, 36000
Site Reference ID/Investigator# 30620
Poltava, 36000
Site Reference ID/Investigator# 30621
Poltava, Poltava
Site Reference ID/Investigator# 30072
Simferopol, 95000
Site Reference ID/Investigator# 30629
Vynnytsya, 21000
Site Reference ID/Investigator# 30631
Vynnytsya, 21000
Site Reference ID/Investigator# 30190
Yevpatoriya, 97400
Site Reference ID/Investigator# 30068
Zaporizhya, 69000
Site Reference ID/Investigator# 30565
Zaporizhya, 69000
Site Reference ID/Investigator# 30566
Zaporizhya, 69000
Site Reference ID/Investigator# 30567
Zaporizhya, 69000
Site Reference ID/Investigator# 30568
Zaporizhya, 69000
Site Reference ID/Investigator# 30570
Zaporizhya, 69000

Other trials in Ukraine

About this study

This postmarketing observational study is non-interventional and is being conducted in a prospective, single-arm, single-country, multicenter format.

Klacid SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population, and indication as well as with local guidelines.

Read the detailed description

The postmarketing observational study is observational in nature. Its follow-up is not interventional and is left to the judgment of each physician during the observational period, which defines the survey for each patient. Follow-up of patients should enable two patient visits during this period.

The screening/inclusion visit (Visit 1) will be performed when the decision for Klacid SR therapy in a daily dose of 1000 mg is made. The second visit of the patient will occur 10 - 16 days from the screening/inclusion Visit (upon physician's decision). The physician can change the numbers and time of the visits. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Conditions: Respiratory Tract Infections
Being tested: Clarithromycin (Klacid SR)
Keywords: Klacid SR, Clarithromycin, Respiratory tract infections, Bronchitis, Pneumonia
Medical subject headings: Respiratory Tract Infections, Bronchitis, Pneumonia

What participants receive

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

Clarithromycin (Klacid SR)Drug
Also called Biaxin, Abbotic, Biclar, Klacid
Klacid SR in a dose of 1000 mg once daily

Study groups in NCT01095978
Study group	Role	What they receive
Acute upper respiratory tract diseases, bronchitis, pneumonia		Not described Receives: Drug: Clarithromycin (Klacid SR)

What is being measured

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

Body Temperature
Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.
Measured: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Cough and Its Character
Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.
Measured: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Dyspnoea
Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.
Measured: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Auscultation Findings
Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.
Measured: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia
Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.
Measured: Visit 1 (Initial visit)
Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)
Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.
Measured: Visit 1 (Initial visit)
Therapeutic Response
Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.
Measured: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)

Secondary outcomes (3)

Adverse Effects
The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details.
Measured: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)
Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason.
Measured: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)
Termination of Treatment
The number of participants who discontinued treatment is summarized.
Measured: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)

Timeline

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

Aug 2009May 2010

First posted30 Mar 2010 (estimated)
Study startAug 2009
Primary completionMay 2010
Study completionMay 2010

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.
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: 2,822 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01095978
Sponsor's protocol ID: P11-979
Acronym: KLARAINE
Status last verified: Jun 2011
First submitted: 28 Feb 2010
Last updated: 11 Jul 2011
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine
ClinicalTrials.gov ID: NCT01095978
Acronym / sponsor ID: KLARAINE / P11-979
Conditions: Respiratory Tract Infections
Keywords: Klacid SR, Clarithromycin, Respiratory tract infections, Bronchitis, Pneumonia
Study type: Observational
Recruitment status: Completed
Enrolment: 2,822 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 30 Mar 2010 (estimated)
Results: Posted 15 Jun 2011

Clinical summary

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

This postmarketing observational study is non-interventional and is being conducted in a prospective, single-arm, single-country, multicenter format.

Klacid SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population, and indication as well as with local guidelines.

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Acute upper respiratory tract diseases, bronchitis, pneumonia	–	Drug: Clarithromycin (Klacid SR)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Consulting rooms of general practitioners, pulmonologists, and allergologists and centers with experience in the treatment of patients with acute upper respiratory tract diseases, acute bronchitis or acute exacerbation of chronic bronchitis or mild community-acquired pneumonia.

Key inclusion criteria (7 listed)

Men, women 18 years with
To whom decision to initiate Klacid SR therapy in a dose of 1000 mg has been made by physician.

Key exclusion criteria (5 listed)

Known hypersensitivity to macrolide antibiotics
Documented renal impairment (creatinine clearance under 30 ml/min)
Concomitant therapy with the following drugs: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine
Pregnancy
Breast feeding

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
Clarithromycin (Klacid SR)Also: Biaxin, Abbotic, Biclar, KlacidKlacid SR in a dose of 1000 mg once daily	Drug	Acute upper respiratory tract diseases, bronchitis, pneumonia

Primary outcome

Body Temperature
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.
Cough and Its Character
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.
Dyspnoea
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.
Auscultation Findings
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.
Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia
Time frame: Visit 1 (Initial visit)
Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.
Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)
Time frame: Visit 1 (Initial visit)
Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.
Therapeutic Response
Time frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.

3 secondary outcomes

Adverse Effects
Time frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)
Time frame: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)
Termination of Treatment
Time frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)

Results and safety

Results posted to the registry on 15 Jun 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Klacid SR	2,822	2,819

Primary outcome: Body Temperature

Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician). Number. Unit: Participants

Measure	Klacid SR (Total) n = 2800	Klacid SR (18 to 64 Years of Age) n = 2604	Klacid SR (65 Years of Age or Older) n = 196
Visit 1: No fever	183	170	13
Visit 1: Fever present	2617	2434	183
a) Fever resolved at Visit 2	1780	1655	125
b) Fever still present at Visit 2	837	779	58

Population analysed: The per-protocol population was analyzed. Visit 2 results are shown for those who had fever at Visit 1.

Primary outcome: Cough and Its Character

Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician). Number. Unit: Participants

Measure	Klacid SR (Total) n = 2800	Klacid SR (18 to 64 Years of Age) n = 2604	Klacid SR (65 Years of Age or Older) n = 196
Visit 1: Did not have cough	118	110	8
Visit 2: Did not have cough	1813	1702	111
Visit 1: Had irritating cough	1671	1563	108
Visit 2: Had irritating cough	237	220	17
Visit 1: Had productive cough	1011	931	80
Visit 2: Had productive cough	749	682	67
Visit 1: Had both types of cough	0	0	0
Visit 2: Had both types of cough	1	0	1

Population analysed: The per-protocol population was analyzed.

Primary outcome: Dyspnoea

Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician). Number. Unit: Participants

Measure	Klacid SR (Total) n = 2800	Klacid SR (18 to 64 Years of Age) n = 2604	Klacid SR (65 Years of Age or Older) n = 196
Visit 1: No dyspnoea	1821	1753	68
Visit 2: No dyspnoea	2608	2451	157
Visit 1: Dyspnoea after exercise	883	766	117
Visit 2: Dyspnoea after exercise	181	143	38
Visit 1: Dyspnoea at rest	95	85	10
Visit 2: Dyspnoea at rest	1	1	0
Visit 1: Both types of dyspnoea	1	0	1
Visit 2: Both types of dyspnoea	10	9	1

Population analysed: The per-protocol population was analyzed.

Primary outcome: Auscultation Findings

Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician). Number. Unit: Participants

Measure	Klacid SR (Total) n = 2800	Klacid SR (18 to 64 Years of Age) n = 2604	Klacid SR (65 Years of Age or Older) n = 196
Visit 1: Normal breath sounds	389	378	11
Visit 2: Normal breath sounds	2494	2350	144
Visit 1: Wheezing	1632	1518	114
Visit 2: Wheezing	184	153	31
Visit 1: Crackles	779	708	71
Visit 2: Crackles	122	101	21
Abnormal breath sounds resolved at Visit 2	2108	1974	134
a) Wheezing resolved at Visit 2	1449	1366	83

Population analysed: The per-protocol population was analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Klacid SR	0 of 2,800 (0%)	14 of 2,800 (0.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Irina Magdik, MD study director

Abbott Laboratories S.A., Ukraine

126 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Tract Infections, run by Abbott at 126 sites in Ukraine.

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 7 inclusion and 5 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 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

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 15 Jun 2011). 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?

Body Temperature (time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)). The study lists 7 primary outcomes in all. 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 NCT01095978.

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 11 Jul 2011.