Clinical trial NCT01076153: Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infection
Keywords: Post-marketing observational study
Upper or lower respiratory tract infection
Klacid MR
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients in Thailand

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Average Time From Baseline to Recovery From Cough and Other Symptoms
timeFrame: Baseline to 14 days
Secondary outcomes:
measure: Number and Type of Adverse Events
timeFrame: Baseline to 14 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27453
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27450
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27448
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 22862
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27444
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27445
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27451
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27452
city: Bangkok
country: Thailand
facility: Site Reference ID/Investigator# 27449
city: Chiangmai
country: Thailand
facility: Site Reference ID/Investigator# 27454
city: Chonburi
country: Thailand
facility: Site Reference ID/Investigator# 27466
city: Chonburi
country: Thailand
facility: Site Reference ID/Investigator# 27465
city: Kanchanaburi
country: Thailand
facility: Site Reference ID/Investigator# 27469
city: Nakhon Phanom
country: Thailand
facility: Site Reference ID/Investigator# 27455
city: Nakonratchasima
country: Thailand
facility: Site Reference ID/Investigator# 27461
city: Nakonratchasima
country: Thailand
facility: Site Reference ID/Investigator# 27462
city: Nakonratchasima
country: Thailand
facility: Site Reference ID/Investigator# 27463
city: Nong khai
country: Thailand
facility: Site Reference ID/Investigator# 27457
city: Nong khai
country: Thailand
facility: Site Reference ID/Investigator# 27458
city: Rayong
country: Thailand
facility: Site Reference ID/Investigator# 27467
city: Songkhla
country: Thailand
facility: Site Reference ID/Investigator# 27470
city: Surat Thani
country: Thailand
facility: Site Reference ID/Investigator# 27472
city: Surat Thani
country: Thailand
facility: Site Reference ID/Investigator# 27471
city: Ubonratchathani
country: Thailand
facility: Site Reference ID/Investigator# 27459
city: Udornthani
country: Thailand
facility: Site Reference ID/Investigator# 27456
city: Utaradit
country: Thailand
facility: Site Reference ID/Investigator# 27464
Study officials:
affiliation: Abbott
name: Savary Om, M.D.
role: STUDY_DIRECTOR
References: