Respiratory Tract InfectionNCT01076153

Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

An observational study of Respiratory Tract Infection, run by Abbott at 26 sites in Thailand.

Completed

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

Trial summary

The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Tract Infection
What is being tested?: Clarithromycin (Klacid® MR)
How many people: 760 participants
Where: 26 sitesThailand
Study dates: Dec 2008to Apr 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: Outpatients in Thailand

Who may be able to join

Patients with upper or lower respiratory tract infection.
Patient is male or female ≥ 18 years of age.

Who cannot join

Known hypersensitivity to or previously intolerant of macrolides.
Illness severe enough to warrant hospitalization or parenteral therapy.
Concomitant use of any of the following medications:
Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
Colchicine

Show all 10Show fewer

Digoxin
Some antiretrovirals: zidovudine and ritonavir.
Severe immunodeficiency and chronic disease conditions.
Renal or hepatic impairment.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

Thailand26 sites

Site Reference ID/Investigator# 27453
Bangkok, 10160
Site Reference ID/Investigator# 27450
Bangkok, 10210
Site Reference ID/Investigator# 27448
Bangkok, 10220
Site Reference ID/Investigator# 22862
Bangkok, 10400
Site Reference ID/Investigator# 27444
Bangkok, 10400
Site Reference ID/Investigator# 27445
Bangkok, 10400
Site Reference ID/Investigator# 27451
Bangkok, 10400
Site Reference ID/Investigator# 27452
Bangkok, 10600
Site Reference ID/Investigator# 27449
Bangkok, 10900
Site Reference ID/Investigator# 27454
Chiang Mai, 50180
Site Reference ID/Investigator# 27466
Chon Buri, 20110
Site Reference ID/Investigator# 27465
Chon Buri, 20150
Site Reference ID/Investigator# 27469
Kanchanaburi, 71000
Site Reference ID/Investigator# 27455
Nakhon Phanom, 48000
Site Reference ID/Investigator# 27461
Nakhon Ratchasima, 30000
Site Reference ID/Investigator# 27462
Nakhon Ratchasima, 30000
Site Reference ID/Investigator# 27463
Nakhon Ratchasima, 30000
Site Reference ID/Investigator# 27457
Nong Khai, 43000
Site Reference ID/Investigator# 27458
Nong Khai, 43110
Site Reference ID/Investigator# 27467
Rayong, 21000
Site Reference ID/Investigator# 27470
Songkhla, 90110
Site Reference ID/Investigator# 27472
Surat Thani, 84000
Site Reference ID/Investigator# 27471
Surat Thani, 84130
Site Reference ID/Investigator# 27459
Ubonratchathani, 34000
Site Reference ID/Investigator# 27456
Udon Thani, 41000
Site Reference ID/Investigator# 27464
Uttaradit, 53000

Other trials in Thailand

About this study

Official title: A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.

Conditions: Respiratory Tract Infection
Being tested: Clarithromycin (Klacid® MR)
Keywords: Post-marketing observational study, Upper or lower respiratory tract infection, Klacid MR
Medical subject headings: Respiratory Tract Infections

What participants receive

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

Clarithromycin (Klacid® MR)Drug
Also called Clarithromycin, Klacid MR, Biaxin XL
Klacid MR 500mg (clarithromycin)

Study groups in NCT01076153
Study group	Role	What they receive
Patients with respiratory tract infection		Thai patients with upper or lower respiratory tract infections on Klacid MR. Receives: Drug: Clarithromycin (Klacid® MR)

What is being measured

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

Average Time From Baseline to Recovery From Cough and Other Symptoms
Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.
Measured: Baseline to 14 days

Secondary outcomes (1)

Number and Type of Adverse Events
Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.
Measured: Baseline to 14 days

Timeline

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

Dec 2008Apr 2010

First posted26 Feb 2010 (estimated)
Study startDec 2008
Primary completionApr 2010
Study completionApr 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 InfectionStudies 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
Observational model: Cohort
Time perspective: Prospective
Enrolment: 760 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01076153
Sponsor's protocol ID: P08-331
Status last verified: Jun 2011
First submitted: 24 Feb 2010
Last updated: 12 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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All Respiratory Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR
ClinicalTrials.gov ID: NCT01076153
Acronym / sponsor ID: P08-331
Conditions: Respiratory Tract Infection
Keywords: Post-marketing observational study, Upper or lower respiratory tract infection, Klacid MR
Study type: Observational
Recruitment status: Completed
Enrolment: 760 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 26 Feb 2010 (estimated)
Results: Posted 29 Jun 2011

Clinical summary

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

The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with respiratory tract infection	–	Drug: Clarithromycin (Klacid® MR)Thai patients with upper or lower respiratory tract infections on Klacid MR.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Outpatients in Thailand

Key inclusion criteria (2 listed)

Patients with upper or lower respiratory tract infection.
Patient is male or female ≥ 18 years of age.

Key exclusion criteria (10 listed)

Known hypersensitivity to or previously intolerant of macrolides.
Illness severe enough to warrant hospitalization or parenteral therapy.
Concomitant use of any of the following medications:
Severe immunodeficiency and chronic disease conditions.
Renal or hepatic impairment.

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® MR)Also: Clarithromycin, Klacid MR, Biaxin XLKlacid MR 500mg (clarithromycin)	Drug	Patients with respiratory tract infection

Primary outcome

Average Time From Baseline to Recovery From Cough and Other Symptoms
Time frame: Baseline to 14 days
Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.

1 secondary outcome

Number and Type of Adverse Events
Time frame: Baseline to 14 days

Results and safety

Results posted to the registry on 29 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 MR	760	749

Primary outcome: Average Time From Baseline to Recovery From Cough and Other Symptoms

Time frame: Baseline to 14 days. Mean (Standard Deviation). Unit: Days

Measure	Klacid MR (Total Number Recovered) n = 658	Klacid MR (URTI, Recovered) n = 491	Klacid MR (LRTI, Recovered) n = 148	Klacid MR (URTI and LRTI, Recovered) n = 19
Value	7.06 (2.65)	6.76 (2.11)	7.82 (3.75)	9.05 (3.08)

Population analysed: The per-protocol population consisted of 694 participants as 66 participants were excluded for protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid MR.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Klacid MR	0 of 760 (0%)	5 of 760 (0.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Savary Om, M.D. study director

Abbott

26 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 Infection, run by Abbott at 26 sites in Thailand.

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 2 inclusion and 10 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 12 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 26 sites in Thailand. 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 29 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?

Average Time From Baseline to Recovery From Cough and Other Symptoms (time frame: Baseline to 14 days). 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 NCT01076153.

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 12 Jul 2011.