Health Condition 1: null- Patients with community acquired infections
Conditions
Interventions
Intervention1: Amoxicillin Tablets (Panacea Biotec Ltd): 250 &
500 mg tablets
Control Intervention1: MOX capsules (Ranbaxy (Rexcel) Pharma): 250 &
500 mg tablets
Sponsors
Panacea Biotec Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 2.2 Upper 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 2.4 Uncomplicated skin and skin structure infections (SSSI) such as simple abscesses, impetiginous lesions, furuncles, and cellulitis 2.5 Acute 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. 2.6 Acute 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).
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the proportion of subjects experiencing diarrhoea* during the treatment between equal dose level of two treatment arms. *Diarrhoea is defined as ?passage of 3 or more loose or liquid stools per day, or more frequently than is normal for the individual? Timepoint: 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the proportion of subjects experiencing diarrhoea during the treatment among treatment arms and all four treatment groups 2. To compare the proportion of patient days exposure to diarrhoea during the treatment among all four treatment groups 3. To compare the proportion of patient days exposure to diarrhoea during the treatment between equal dose level of two treatment arms 4. To compare the clinical response* at the end of the study treatment between the equal doses of two treatment arms *The clinical response will be defined as Clinical Cure: Resolution of signs and symptoms associated with active infection, and no further antimicrobial therapy is required Clinical Improvement: Incomplete resolution of signs and symptoms. Clinical Failure: No response to therapy. Unable to Evaluate: Not able to evaluate because subject lost to follow-up. 5. Mean of the first day occurrence of diarrhoea will be compared between equal doses of two treatment arms and also among all four treatment arms 6. Day-wise distribution of diarrhea in various treatment groups 7. Mean of the number of continuous episodes of diarrhoea will be compared between treatment arms and also among all the four groups 8. Counts of consistency of stool (by maximum severity) will be compared between treatment arms and also among all the four groups 9. To compare the mean frequency of stool (max frequency considered) between treatment arms and among all four groups 10. Incidence of clinical and laboratory adverse event between equal dose level of the treatment groups and among all four treatment arms except for the incidence of diarrhoea Timepoint: 10 days | — |
Countries
India
Contacts
Public ContactDr. Arani Chatterjee
Sr VP
Outcome results
None listed