A clinical trial to study the effects of two drugs, cefopodoxime and dicloxacillin in patients with various bacterial respiratory tract infections.

?A control labeled, double arm, comparative, multicentric, prospective, Phase III trial to compare the safety and efficacy of fixed dose combination of Cefpodoxime 200mg and Dicloxacillin 500mg with Cefpodoxime 200mg in subjects suffering with various bacterial respiratory tract infections.?

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2010/091/000589

Enrollment

200

Registered

2010-07-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- bacterial respiratory tract infections

Interventions

Intervention1: Cefpodoxime 200mg and Dicloxacillin 500mg: once daily Control Intervention1: Cefpodoxime 200mg and Dicloxacillin 500mg: twice daily

Eligibility

Inclusion criteria

Inclusion criteria: -Male and female subjects in the age of 18-70 years shall be selected. - Subjects suffering from respiratory tract infections. -Subjects with normal RFT &LFT. - Subjects willing to give informed consent

Exclusion criteria

Exclusion criteria: - Patients with significant primary insufficency including both intrinsic lung disease and respiratory failure. - Patients with pulmonary tuberculosis. - Patients with a history of known hypersensitivity from any one of the said medication. - Patients with acute myocardial infaraction, hypotension. - patients with uncontrolled hypertension. _ subjects with severe hepatic, renal failure or encephalopathy. - Chronic alcoholics. - Patients with histiry of cardiac surgery. -Pregnant & lactating women.

Design outcomes

Primary

Measure	Time frame
Improvement in clinical and bacteriological/radiological parameters of the FDC of Cefopodoxime and Dicloxacillin in subjects with above mentioned infections.Timepoint: 5 and 10 days	—

Secondary

Measure	Time frame
To see the safety and tolerability of FDC by observing the incidence of adverse events as assessed by clinical evaluation and laboratory parametersTimepoint: 5 to 10 days	—

Countries

India

Contacts

Public ContactDr. Nitin M Rathod

nitinmr@yahoo.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026