Trial Outcomes & Findings for Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections (NCT NCT00827502)

Last Updated: 2011-04-28

Results Overview

Success: Cure (disappearance of all pre-treatment signs and symptoms of infection) or improvement in or partial disappearance of signs and symptoms not requiring further treatment at end of study; Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. Unknown or missing values were considered as failure.

Recruitment status

COMPLETED

Target enrollment

421 participants

Primary outcome timeframe

Baseline to 2 weeks

Results posted on

2011-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Azithromycin The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg.
Overall Study STARTED	421
Overall Study Received Treatment (Number Treated)	410
Overall Study COMPLETED	400
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Azithromycin The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg.
Overall Study randomized but not treated	11
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Trulimax (Azithromycin ) Non-Interventional Study In Acute Bacterial Upper Respiratory Tract Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Azithromycin n=410 Participants
Age, Customized <18 years	51 participants n=5 Participants
Age, Customized 18-44 years	270 participants n=5 Participants
Age, Customized 45-64 years	73 participants n=5 Participants
Age, Customized >= 65 years	9 participants n=5 Participants
Age, Customized Unspecified	2 participants n=5 Participants
Age, Customized Demographic information not collected	5 participants n=5 Participants
Sex/Gender, Customized Female	155 participants n=5 Participants
Sex/Gender, Customized Male	245 participants n=5 Participants
Sex/Gender, Customized Unspecified	5 participants n=5 Participants
Sex/Gender, Customized Demographic information not collected	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 2 weeks

Population: The full analysis set (FAS) included all subjects who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Azithromycin n=408 Participants
Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study Success	275 participants
Number of Subjects With an Investigator Assessment of Clinical Outcome (Success/Failure) at End of Study Failure (Unknown or missing values also included)	133 participants

PRIMARY outcome

Timeframe: Baseline to 2 weeks

Population: The efficacy evaluable (EVAL) population included subjects in the FAS having at least 1 definitive follow up global response assessment to treatment of URTIs.

Cure: Disappearance of all pre-treatment signs and symptoms of infection; Improvement: Improvement in, or partial disappearance of signs and symptoms without requiring further antibacterial therapy. Subjects who discontinued study drug for reasons other than lack of clinical response, i.e., despite clinical improvement, were included in this category; and Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, ie, addition of or switch to another systemic antibacterial therapy. An unknown response or missing value was considered clinical failure.

Outcome measures

Outcome measures
Measure	Azithromycin n=278 Participants
Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study Cure	249 Participants
Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study Improvement	26 Participants
Number of Subjects With an Investigator Assessment of Clinical Outcome (Cure/Improvement/Failure) at End of Study Failure	3 Participants

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: FAS

Cost (in Indian Rupees) per participant of utilizations including general consultations over the study; each medication over the study (study drug, analgesics, antipyretics, anti-inflammatory drugs, vitamins, other study medication), radiological tests over the study (chest X-ray); and clinical laboratory tests over the study (complete blood count and erythrocyte sedimentation rate).

Outcome measures

Outcome measures
Measure	Azithromycin n=410 Participants
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate Overall Study Drugs (n=390)	170 cost (in Indian Rupees) per participant Interval 85.0 to 272.0
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate Analgesics (n=205)	18 cost (in Indian Rupees) per participant Interval 2.0 to 112.0
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate Antipyretics (n=116)	9 cost (in Indian Rupees) per participant Interval 1.0 to 21.0
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate Anti-inflammatory (n=88)	20 cost (in Indian Rupees) per participant Interval 2.0 to 84.0
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate Vitamins (n=180)	20 cost (in Indian Rupees) per participant Interval 2.0 to 70.0
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate Other study medication (n=235)	20 cost (in Indian Rupees) per participant Interval 2.0 to 96.0
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate Chest X-ray (n=9)	150 cost (in Indian Rupees) per participant Interval 150.0 to 150.0
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate Complete Blood Count (n=15)	200 cost (in Indian Rupees) per participant Interval 200.0 to 200.0
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate Erythrocyte Sedimentation Rate (n=4)	80 cost (in Indian Rupees) per participant Interval 80.0 to 80.0
Cost (in Indian Rupees) Per Participant of Utilizations Including General Consultations, Medications, Chest X-ray, Complete Blood Count, and Erythrocyte Sedimentation Rate General Consultations (n=346)	500 cost (in Indian Rupees) per participant Interval 150.0 to 1300.0

Adverse Events

Azithromycin

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Azithromycin n=410 participants at risk
Blood and lymphatic system disorders Lymphadenopathy	0.24% 1/410
Gastrointestinal disorders Abdominal discomfort	0.24% 1/410
Gastrointestinal disorders Abdominal pain	0.24% 1/410
Gastrointestinal disorders Abdominal pain upper	0.24% 1/410
Gastrointestinal disorders Diarrhoea	1.2% 5/410
Gastrointestinal disorders Dry mouth	0.24% 1/410
Gastrointestinal disorders Flatulence	0.49% 2/410
Gastrointestinal disorders Gastric disorder	0.24% 1/410
Gastrointestinal disorders Hyperchlorhydria	0.24% 1/410
General disorders Adverse event	0.24% 1/410
General disorders Drug intolerance	0.24% 1/410

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER