A clinical trial to study the effect of amoxicillin tablets in patients with community acquired infections
- Conditions
- Health Condition 1: null- Patients with community acquired infections
- Registration Number
- CTRI/2011/091/000207
- Lead Sponsor
- Panacea Biotec Ltd
- 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.Lower respiratory tract infection (LRTI) defined as any abnormality on pulmonary auscultation and at least two of the following three signs and symptoms:
?fever >38°C, or fever in the past 48 hours;
?dyspnoea or cough (productive or non-productive)
?tachypnoea
2.2Upper respiratory tract infection (URTI) defined as at least one from each of the following groups of URTIs symptoms:
?Symptoms of infection: headache, chills, muscle ache, or an oral temperature greater than 37.5 degrees Celsius.
?Symptoms from the upper respiratory tract: cough, hoarseness, running nose, nasal obstruction, itchy throat, sore throat or sneezing.
2.3 Urinary 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
2.4Uncomplicated skin and skin structure infections (SSSI) such as simple abscesses, impetiginous lesions, furuncles, and cellulitis
2.5Acute 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.
2.6Acute uncomplicated ano-genital and urethral infections- which is diagnosed in men by characteristic symptoms of acute urethritis are mucoid or purulent urethral discharge and dysuria (generally without urgency or frequency). And in women, the symptoms include vaginal discharge, intermenstrual spotting and bleeding, urethral discharge, or dysuria (generally without urgency or frequency).
1.Subjects requiring hospitalization
2.Subjects with diarrhoea
3.Subjects with known or suspected hypersensitivity to amoxicillin 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
Lower respiratory tract infection
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.
Upper respiratory tract infection
1.History of persistent asthma or other chronic diseases.
2.Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
3.Patients with evidence of significant nasal septal deviation
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: 10 days
- Secondary Outcome Measures
Name Time Method