A clinical trial to study the effect of Amoxicillin and Clavulanate potassium tablets in patients of community acquired infections
- Conditions
- Health Condition 1: null- Community acquired infections
- Registration Number
- CTRI/2010/091/000612
- Lead Sponsor
- Panacea Biotec Ltd New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 192
1.Subjects 18 years or more of either sex who are able to give voluntary written informed consent
2.Subjects suffering from any of the following and suitable for outpatient treatment:
2.1.Community acquired pneumonia based on the following clinical and radiological criteria:
a) Clinical: A patient should have at least three of the following symptoms and signs:
i.Cough with production of purulent sputum
ii.Dyspnea or tachypnea
iii.Chest pain
iv.Fever, body temperature >38oC (100.4oF) taken orally; or hypothermia ( <35oC)
v.Clinical findings of pulmonary consolidation
b) Radiographic: The chest radiograph should show the presence of new infiltrates in a lobar or multilobar distribution characteristic of bacterial pneumonia.
2.2Urinary tract infection which is diagnosed by any of the following:
a)Dysuria, frequency, urgency, suprapubic pain with onset of symptoms ≤72 hours prior to study entry.
b)One positive pre-treatment clean-catch mid-stream urine culture within 48 hours of enrollment in the study, defined as >105 CFU/mL.
2.3Uncomplicated skin and skin structure infections (SSSI) such as simple abscesses, impetiginous lesions, furuncles, and cellulitis.
2.4Acute sinusitis which is diagnosed by history of signs and symptoms (facial pain/ pressure/ tightness typically over the maxillary sinuses, a purulent nasal discharge and cough) lasting for longer than 7 days, but less than 28 days.
1.Subjects requiring hospitalization
2.Subjects with diarrhoea
3.Subjects with known or suspected hypersensitivity to amoxicillin, clavulanate potassium or any the constituents of the formulation.
4.Subjects who have received any other investigational drug within 1 month prior to screening or enrollment.
5.Subjects who have received antimicrobial therapy within 7 days prior to enrollment.
6.Subjects who are receiving other medications or who have other disease conditions that could interfere with the evaluation of drug efficacy or drug safety.
7.Pregnant, lactating women. Women in post-partum period of up to 6 weeks
8.Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner, during the study therapy.
9.Has uncontrolled diabetes mellitus
10.Has active liver disease, or jaundice
11.Subjects with any concomitant condition that, in the opinion of the investigator that could interfere with the evaluation of drug efficacy or drug safety.
12.Subjects with infection that needs an additional antibiotic.
13.Subjects with renal failure who are on hemodialysis, peritoneal dialysis, plasmapheresis, or hemoperfusion.
Indication Specific Exclusion Criteria
Community-Acquired Pneumonia
1.Subjects with known bronchial obstruction or a history of post-obstructive pneumonia. (This does not exclude patients who have chronic obstructive pulmonary disease.)
2.Subjects with primary lung cancer or another malignancy metastatic to the lungs should be excluded.
3.Subjects with cystic fibrosis, AIDS, or those with known or suspected active tuberculosis should be excluded.
Urinary Tract Infection
1.Three or more episodes of acute uncomplicated UTI in the past 12 months
2.Subjects with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, etc.
3.Subjects with a temperature >1010 F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection
Uncomplicated Skin and Superficial Skin Structure Infections
1.Infections that have a high cure rate after surgical incision alone (such as isolated furunculosis) or after aggressive local skin care (such as a minor skin infection) should not be enrolled.
2.For complicated skin infections, medical conditions leading to difficulty in interpreting response
Acute Sinusitis
1.Subjects with sub-acute sinusitis (>28 to <90 days) and chronic sinusitis (>90 days)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare the proportion of subjects experiencing diarrhoea* during the treatment between equal dose level of two treatment arms.<br>*Diarrhoea is defined as ?passage of 3 or more loose or liquid stools per day, or more frequently than is normal for the individual? <br>Timepoint: At the end of 10 days of treatment duration
- Secondary Outcome Measures
Name Time Method 1.To compare the clinical response* at the end of the study treatment between the equal dose level of two treatment arms<br>*The clinical response will be defined as<br>&#61607;Clinical Cure: Resolution of signs and symptoms associated with active infection , and no further antimicrobial therapy is required<br>&#61607;Clinical Improvement: Incomplete resolution of signs and symptoms.<br>&#61607;Clinical Failure: No response to therapy.<br>&#61607;Unable to Evaluate: Not able to evaluate because subject lost to follow-up. <br>2.To compare the proportion of subjects experiencing diarrhoea during the treatment between two treatment arms.<br>3.Incidence of clinical and laboratory adverse event between equal dose level of the treatment groups except for the incidence of diarrhoea <br>Timepoint: At the end of 10 days of treatment duration