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Quinolone antibiotics for the prevention of bacterial superinfection after COVID-19 infection:a randomised, controlled, open-label, platform trial

Quinolone antibiotics for the prevention of bacterial superinfection after COVID-19 infection:a randomised, controlled, open-label, platform trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077260
Enrollment
Unknown
Registered
2023-11-02
Start date
2023-06-19
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

COVID-19

Interventions

The treatment group:standard care plus Quinolone antibiotics at a dose of 500 mg once daily for 7 days
control group:standard care

Sponsors

Seventh Medical Center, Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.SARS-Cov-2 infection (RT-PCR test or antigen dectection for SARS-CoV-2 was performed and it is positive) 2.At the time of visit or admission, no acute active bacterial infection was present (last blood routine: WBC < 10 ×10^9/L, N < 70%). 3. Fewer than 7 days since symptom onset or aggravation of pre-existing symptoms

Exclusion criteria

Exclusion criteria: 1.No Informed Consent; 2.Use of any type of antibiotic in the week prior to recruitment; 3.History of severe ventricular cardiac arrhythmia or electrocardiogram with corrected QT interval (QTc) =480 ms; 4.With severe liver disease (total bilirubin (TBIL) =2 times the upper limit of normal, alanine aminotransferase (ALT), aspartate aminotransferase (AST) =3 times the upper limit of normal); 5.Chronic renal failure (estimated glomerular filtration rate <30 mL/min/1.73 m2); 6.History of epilepsy; 7.History of myasthenia gravis; 8.Known allergy to quinolone; 9.Age: <18 years old; 10.Pregnant and lactating women or those who planned to have children during the trial period and within 6 months after the end of the trial; 11.People who are participating in other clinical trials or are using an investigational drug.

Design outcomes

Primary

MeasureTime frame
the incidence of bacterial superinfections within 28 days after COVID-19;

Secondary

MeasureTime frame
Incidence of Quinolone antibiotics-related adverse events and serious adverse events (D1-D28);all-cause mortality within 28 days;Duration of symptoms associated with COVID-19;The duration of hospital stay ;7-level ordinal scale at 7,14 and 28days (Compared with baseline);

Countries

China

Contacts

Public ContactDe Chang

Seventh Medical Center, Chinese PLA General Hospital

changde@301hospital.com.cn+86 138 1104 9022

Outcome results

None listed

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