Lower Respiratory Tract InfectionNCT01076166

Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.

An observational study of Lower Respiratory Tract Infection, run by Abbott at 16 sites in Thailand.

Completed

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

Trial summary

Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections. Read more about this study

Who is it for?: Ages 6 months to 12 years
Conditions the study is for: Lower Respiratory Tract Infection
What is being tested?: clarithromycin (Klacid) granules for oral suspension
Type of treatment: Pill or oral medicine
How many people: 337 participants
Where: 16 sitesThailand
Study dates: Apr 2009to Jan 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 6 months to 12 years
All sexes
No healthy volunteers
Child

Study population: Out-patients in Thailand

Who may be able to join

Patients with lower respiratory tract infection.
Patient is male or female > 6 months and < 12 years of age.
Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients
Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information

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
Ritonavir.
Severe immunodeficiency and chronic disease conditions.
Renal or hepatic impairment.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Thailand16 sites

Site Reference ID/Investigator# 27424
Bangkok, 10110
Site Reference ID/Investigator# 46824
Bangkok, 10120
Site Reference ID/Investigator# 16261
Bangkok, 10160
Site Reference ID/Investigator# 46825
Bangkok, 10160
Site Reference ID/Investigator# 27428
Bangkok, 10220
Site Reference ID/Investigator# 27425
Bangkok, 10260
Site Reference ID/Investigator# 27423
Bangkok, 10700
Site Reference ID/Investigator# 27426
Bangkok, 10900
Site Reference ID/Investigator# 46823
Chiang Mai, 50180
Site Reference ID/Investigator# 27434
Chumphon, 86000
Site Reference ID/Investigator# 27433
Chumphon, 86110
Site Reference ID/Investigator# 27431
Nakhon Ratchasima, 30000
Site Reference ID/Investigator# 27441
Nong Khai, 43110
Site Reference ID/Investigator# 27429
Phitsanulok, 65000
Site Reference ID/Investigator# 27432
Rayong, 21000
Site Reference ID/Investigator# 27430
Samutsakorn, 74000

Other trials in Thailand

About this study

Official title: A Multi-center, Post-Marketing Observational Study to Identify the Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid Granules for Oral Suspension.

Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.

Conditions: Lower Respiratory Tract Infection
Being tested: clarithromycin (Klacid) granules for oral suspension
Keywords: Post-marketing observational study, Lower respiratory tract infections, Klacid Granules for Oral Suspension

What participants receive

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

clarithromycin (Klacid) granules for oral suspensionDrug
Also called clarithromycin, Klacid Granules for Oral Suspension, Biaxin XL
clarithromycin (Klacid) Granules for Oral Suspension

Study groups in NCT01076166
Study group	Role	What they receive
Children with lower respiratory tract infection		Thai children with lower respiratory tract infections on Klacid Granules for Oral Suspension Receives: Drug: clarithromycin (Klacid) granules for oral suspension

What is being measured

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

Average Time From Baseline to Recovery From Fever and Other Symptoms
Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment 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, fever, cough, chest/abdominal pain, and vomiting. 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 are 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.

Apr 2009Jan 2010

First posted26 Feb 2010 (estimated)
Study startApr 2009
Primary completionJan 2010
Study completionJan 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 Lower 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: 337 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01076166
Sponsor's protocol ID: P10-813
Status last verified: Apr 2011
First submitted: 24 Feb 2010
Last updated: 11 Apr 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

RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia

All Lower Respiratory Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 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 Children With Lower Respiratory Tract Infections Treated With Klacid Granules for Oral Suspension.
ClinicalTrials.gov ID: NCT01076166
Acronym / sponsor ID: P10-813
Conditions: Lower Respiratory Tract Infection
Keywords: Post-marketing observational study, Lower respiratory tract infections, Klacid Granules for Oral Suspension
Study type: Observational
Recruitment status: Completed
Enrolment: 337 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 26 Feb 2010 (estimated)
Results: Posted 7 Mar 2011

Clinical summary

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

Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.

Study design

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

Arm	Type	Receives
Children with lower respiratory tract infection	–	Drug: clarithromycin (Klacid) granules for oral suspensionThai children with lower respiratory tract infections on Klacid Granules for Oral Suspension

Who may qualify

Ages: 6 months to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Out-patients in Thailand

Key inclusion criteria (4 listed)

Patients with lower respiratory tract infection.
Patient is male or female > 6 months and < 12 years of age.
Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients
Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information

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) granules for oral suspensionAlso: clarithromycin, Klacid Granules for Oral Suspension, Biaxin XLclarithromycin (Klacid) Granules for Oral Suspension	Drug	Children with lower respiratory tract infection

Primary outcome

Average Time From Baseline to Recovery From Fever and Other Symptoms
Time frame: Baseline to 14 days
Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment 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, fever, cough, chest/abdominal pain, and vomiting. 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 7 Mar 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 Granules (Total)	337	328

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

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

Measure	Klacid Granules (Total Number Recovered) n = 171	Klacid Granules (Bronchitis, Recovered) n = 163	Klacid Granules (Pneumonia, Recovered) n = 8
Value	7.18 (2.33)	7.14 (2.35)	7.88 (1.81)

Population analysed: A total of 29 patients were excluded for protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2). Average time to recovery was based on 171 recovered patients.

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Klacid Granules (Total)	2 of 337 (0.6%)	1 of 337 (0.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

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

Related trials for Lower Respiratory Tract Infection

RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia

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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Respiratory Tract Infection, run by Abbott at 16 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 4 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 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 7 Mar 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 Fever 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 NCT01076166.

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 Apr 2011.