Exposure to antibiotic tablets during the acute phase of an infection in patients with fever

Phase 1

• Conditions: Exposure to oral antibiotics will be investigated in infectious patients when they are febrile compared to when they are afebrile. The infection itself is unspecified.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2019-001240-21-NL
• Lead Sponsor: Amsterdam UMC, location AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Age =18 years Acute febrile illness, defined as a temperature =38.5 and in need of IV antibiotic therapy for an infection for which amoxicillin or ciprofloxacin are registered treatments
Admitted to the internal medicine (including gastroenterology and pulmonology ward)
Able to take oral medication, that is no abdominal pathology or history of abdominal pathology that may alter absorption (i.e. vomiting, mucositis, diarrhoea, malabsorption syndrome, former abdominal surgery affecting absorption)
Able and willing to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Critically ill patients, admitted to the ICU, or infectious patients of the general ward who became critically ill and got transferred to the ICU during the research period.
Comorbidity affecting absorption: hepatic impairment, i.e. active hepatitis, hepatic failure, liver cirrhosis or severe renal impairment (GFR <30),
Neutropenic patients (neutrophil count <1000/µl) and patients treated with chemotherapy within 28 days prior to the study.
Contraindications to use ciprofloxacin or amoxicillin
o Ciprofloxacin: allergy to fluoroquinolones, concomitant administration of tizanidine
o Amoxicillin: allergy to penicillins or proven allergy to another beta-lactam agent (e.g. cephalosporin, carbapenem or monobactam).
Penicillin/fluoroquinolone treatment during the week prior to study enrolment
Pregnancy
History of alcohol and drug abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to determine if the exposure to oral ciprofloxacin and amoxicillin is altered in hospitalized non-critically ill, febrile patients in need of IV antibiotics when they are acutely ill and febrile, compared to when they are afebrile.;Secondary Objective: The secondary objective is to determine if target attainment can be achieved with current oral treatment dosage regimens.;Primary end point(s): The primary endpoint is the AUC, calculated after oral administration of ciprofloxacin and amoxicillin, which will be compared between the febrile and afebrile phase. ;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated after all patients of the initial sample size calculation have been included.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints are the Cmax and Tmax, calculated after oral administration of ciprofloxacin and amoxicillin, which will be compared between the febrile and afebrile phase. In addition, the percentage of patients that achieve target attainment will be assessed in both phases.;Timepoint(s) of evaluation of this end point: The endpoints will be evaluated after all patients of the initial sample size calculation have been included.