An Observational Study to Evaluate the Safety and Tolerability of Minocycline Hydrochloride Injection in Indian Patients with Multi Drug Resistant Gram-Negative Bacterial Infections.

An Observational, Practice based, Open label, Prospective Non Comparative, Multicenter, Post Marketing Surveillance Study to Assess Safety and Tolerability of Minocycline Hydrochloride 100 mg Intravenous (I.V.) Injection in Indian Patients with Multi-Drug Resistant Gram (MDR) Negative Bacterial Infections.

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/04/013319

Enrollment

Registered

2018-04-17

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: A499- Bacterial infection, unspecified Health Condition 2: null- The patients with Multi Drug Resistant Gram Negative Bacterial Infections.

Interventions

Intervention1: Minocycline hydrochloride (Divaine 100 mg): Subjects will be administered with 200 mg/day in 2 divided doses (Intravenous infusion)

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written signed and dated informed consent (patient or LAR) 2. Either gender with age 18 years and above 3. Patients with Multi-Drug Resistant (MDR) gram negative bacterial infection 4. Documented bacteriological infection susceptible to Minocycline Hydrochloride.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to Minocycline Hydrochloride or any of its components 2. Patient unsuitable to participate in the study as per the discretion of investigator 3. Pregnant or nursing females 4. Any other condition in the opinion of the investigator would affect the safety of the patient if Minocycline Hydrochloride is administered.

Design outcomes

Primary

Measure	Time frame
1.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related) 2.Percentage of patients with adverse events 3.Treatment discontinuation ratesTimepoint: During Treatment period	—

Secondary

Measure	Time frame
Not applicableTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactMr Satish Marukurthi

Cipla Ltd.

Sandesh.sawant3@cipla.com022-24814909

Outcome results

None listed

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