#1 Clinical Trials Search in Europe

Ciprofloxacin Hydrochloride Monohydrate

This article discusses the use of Ciprofloxacin Hydrochloride Monohydrate in clinical trials for treating prosthetic joint infections. The drug is being studied as part of a combination therapy in comparison with other antibiotics for patients who have undergone surgical debridement. The trial aims to evaluate the effectiveness and safety of different antibiotic regimens in managing these complex infections.

Table of Contents

What is Ciprofloxacin Hydrochloride Monohydrate?

Ciprofloxacin Hydrochloride Monohydrate is an active substance used in certain medications. It belongs to a class of antibiotics known as fluoroquinolones[1]. These antibiotics work by killing bacteria or preventing their growth, making them effective against various bacterial infections.

Medical Uses

While the specific clinical trial data provided doesn’t detail all the uses of Ciprofloxacin Hydrochloride Monohydrate, it’s generally used to treat a variety of bacterial infections. In the context of the clinical trial mentioned, it was being considered as part of a treatment regimen for prosthetic joint infections (PJIs)[1]. PJIs are serious complications that can occur after joint replacement surgery, where bacteria infect the area around the artificial joint.

Ciprofloxacin is often used to treat infections caused by various bacteria, including those that affect the:

  • Urinary tract
  • Respiratory system
  • Gastrointestinal system
  • Skin and soft tissues
  • Bones and joints (as in the case of prosthetic joint infections)

How is it Administered?

According to the information provided, Ciprofloxacin Hydrochloride Monohydrate is administered orally[1]. The specific medication mentioned in the trial data is Ciprofloxacin-ratiopharm® 500 mg Film-coated Tablets. As the name suggests, these are film-coated tablets that are taken by mouth.

Dosage Information

The dosage of Ciprofloxacin can vary depending on the specific condition being treated and individual patient factors. However, the trial data provides some general information about dosing[1]:

  • The maximum daily dose is 1000 mg (1 gram)
  • The maximum total dose amount is 84,000 mg (84 grams)
  • The maximum treatment period is 12 weeks

It’s crucial to note that these are maximum amounts, and actual prescribed doses may be lower. Always follow your healthcare provider’s instructions regarding dosage and duration of treatment.

Alternative Names

Ciprofloxacin Hydrochloride Monohydrate is known by several other names, which may appear on medication labels or in medical literature[1]:

  • BAY-O-9867 Monohydrate
  • Ciprofloxacin Monohydrochloride Monohydrate
  • Ciprofloxacin Hydrochloride Hydrate
  • Ciprofloxacine Hydrochloride Monohydrate

Important Considerations

While Ciprofloxacin is an effective antibiotic, there are some important points to consider:

  • It’s a prescription medication and should only be taken under medical supervision.
  • The full course of antibiotics should be completed as prescribed, even if you start feeling better before it’s finished.
  • Ciprofloxacin can interact with other medications, so inform your doctor about all medicines you’re taking.
  • Like all antibiotics, Ciprofloxacin can potentially lead to antibiotic resistance if misused.
  • It may not be suitable for everyone, including pregnant women or those with certain pre-existing conditions.

Always consult with your healthcare provider for personalized advice and information about using Ciprofloxacin Hydrochloride Monohydrate[1].

Aspect Details
Trial Name The RiCOTTA trial
Main Objective Compare targeted monotherapy with clindamycin to rifampicin/fluoroquinolones combination treatment for prosthetic joint infections
Study Drug Ciprofloxacin Hydrochloride Monohydrate (as part of the fluoroquinolone group)
Condition Studied Prosthetic joint infection (hip or knee)
Primary Endpoint Treatment success 15 months after surgical debridement
Secondary Endpoints Quality of life, adverse events, antibiotic switches, side effects, C. difficile infection, antibiotic resistance
Treatment Duration 12 weeks of antibiotic treatment
Follow-up Period 15 months after surgical debridement
Drug Formulation Film-coated tablet
Maximum Daily Dose 1000 mg
Route of Administration Oral

FAQ

  • What is the main purpose of the clinical trial using Ciprofloxacin Hydrochloride Monohydrate? The main purpose is to compare the effectiveness of different antibiotic regimens, including Ciprofloxacin Hydrochloride Monohydrate, in treating prosthetic joint infections after surgical debridement.
  • Who is eligible to participate in this clinical trial? Adult patients (18 years or older) diagnosed with hip or knee prosthetic joint infections caused by Staphylococcus bacteria and treated with surgical debridement are eligible to participate.
  • What is the duration of the antibiotic treatment in this trial? The initial antibiotic treatment lasts for 12 weeks, with a follow-up period extending to 15 months after the surgical procedure.
  • How is treatment success defined in this clinical trial? Treatment success is defined as the absence of infection-related re-surgery, no new antibiotic treatment for the affected joint, no ongoing antibiotic use for the joint at the end of follow-up, and survival of the patient.
  • What are some of the side effects being monitored in this trial? The trial monitors for adverse events, including antibiotic side effects, development of Clostridioides difficile infection, and the occurrence of antibiotic resistance in cases of treatment failure.

Ongoing Clinical Trials on Ciprofloxacin Hydrochloride Monohydrate

  • Study Comparing Clindamycin to Rifampicin and Drug Combination for Patients with Prosthetic Joint Infection

    Recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

Glossary

  • Prosthetic Joint Infection (PJI): An infection that occurs around artificial joint implants, such as hip or knee replacements.
  • DAIR: Stands for Debridement, Antibiotics, and Implant Retention. It's a surgical procedure used to treat prosthetic joint infections while keeping the implant in place.
  • Staphylococcus: A type of bacteria that can cause various infections, including prosthetic joint infections.
  • Ciprofloxacin Hydrochloride Monohydrate: An antibiotic medication used to treat various bacterial infections, including those affecting bones and joints.
  • Rifampicin: An antibiotic often used in combination with other drugs to treat various infections, including prosthetic joint infections.
  • Fluoroquinolones: A class of antibiotics that includes Ciprofloxacin, used to treat a wide range of bacterial infections.
  • Clostridioides difficile: A type of bacteria that can cause severe diarrhea and other intestinal problems, especially in patients taking antibiotics.
  • EQ-5D-5L: A standardized questionnaire used to measure health-related quality of life in clinical trials and health economic evaluations.

References

  1. http://clinicaltrials.eu/trial/study-comparing-clindamycin-to-rifampicin-and-drug-combination-for-patients-with-prosthetic-joint-infection/