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Pilot Study of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia

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ClinicalTrials.gov Identifier: NCT04709172
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Meiji Pharma Spain S.A.

Brief Summary:

The global pandemic of novel coronavirus disease 2019 (COVID-19) began in Wuhan, China, in December 2019, and has since spread worldwide. The disease is mild in 85% of cases but the remaining 15% requires hospitalization and/or intensive care.

Recent publications show that a significant number of COVID-19 patients are co-infected with one or more pathogens. Most co-infections occurred within 1-4 days of onset of COVID-19 disease and a considerable number of patients arrive to the Emergency rooms with mild-moderate respiratory symptoms compatible with pneumonia of presumed bacterial origin and not severe enough for requiring hospitalization. It therefore seems reasonable to adopt therapeutic strategies for these patients that are effective and easy to follow in the outpatient setting.

Cefditoren (CDN) is a third-generation cephalosporin for oral administration. CDN has a broad spectrum of activity and is particularly active against the bacterial pathogens involved in community respiratory tract infections. Besides that, the use of CDN has been associated with a marked decrease in circulating levels of IL-6 and other pro-inflammatory cytokines and mediators of epithelial damage. The aim of this study is to demonstrate that CDN improves clinical condition in patients with mild-moderate COVID-19 and symptoms of bacterial pneumonia.


Condition or disease Intervention/treatment Phase
COVID-19 Pneumonia Drug: Cefditoren pivoxil 400mg Phase 4

Detailed Description:

The global pandemic of novel coronavirus disease 2019 (COVID-19) began in Wuhan, China, in December 2019, and has since spread worldwide. The novel coronavirus is now referred to as severe and critical acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The disease is mild in 85% of cases but the remaining 15% requires hospitalization and/or intensive care.

Recent publications show that a variable number of COVID-19 patients are co-infected with one or more pathogens. Most co-infections occurred within 1-4 days of onset of COVID-19 disease and in a retrospective study, secondary infection was observed in 50% of non-survivor patients.

In COVID-19 patients the elevated inflammatory cytokines and other inflammatory mediators present suggest that a cytokine storm, also known as cytokine release syndrome (CRS), may play a major role in the pathology of this disease. The elevated cytokine levels, specifically IL-6, may also be responsible for the lethal complications of COVID-19. Therefore, the interleukin-6 (IL-6) blockade has been proposed as one of the strategies to manage COVID-19-induced CRS.

A considerable number of COVID-19 patients arrive to the Emergency rooms with mild-moderate respiratory symptoms compatible with pneumonia of presumed bacterial origin not severe enough for requiring hospitalization. It therefore seems reasonable to adopt therapeutic strategies for these patients that are effective and easy to follow in the outpatient setting to avoid overloading the Health System.

Cefditoren (CDN) is a third-generation cephalosporin for oral administration. CDN has a broad spectrum of activity and is particularly active against the bacterial pathogens involved in community respiratory tract infections. The results of clinical trials with CDN on community-acquired pneumonia showed percentages of clinical and microbiological efficacy around 85%. On the other hand, the use of CDN has been associated with a marked decrease in circulating levels of IL-6 and other pro-inflammatory cytokines and mediators of epithelial damage such as Krebs von den Lungen-6 (KL-6).

Considering the above and the current estate of knowledge against SARS-CoV-2, we have considered of relevance to study the efficacy of CDN in a series of patients with mild-moderate COVID-19 and with symptoms compatible with pneumonia of presumed bacterial origin, seen at the Emergency room of a public hospital and followed on outpatient basis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Non-controlled Pilot Study to Evaluate the Efficacy and Safety of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia
Actual Study Start Date : January 5, 2021
Estimated Primary Completion Date : April 5, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Cefditoren pivoxil 400mg
Cefditoren pivoxil 400mg bid for 7 days
Drug: Cefditoren pivoxil 400mg
Cefditoren pivoxil 400mg bid for 7 days
Other Name: CDN-PI 400mg




Primary Outcome Measures :
  1. Evolution of patient status [ Time Frame: 28 days ]
    Evolution of the status of the patient defined by the World Health Organization Ordinal Scale for Clinical Improvement for COVID-19. This is a 0-8 score where higher scores mean a better or worse outcome.

  2. Assessment of Clinical improvement [ Time Frame: 28 days ]
    Evaluation of clinical condition through a Clinical Improvement questionnaire.


Secondary Outcome Measures :
  1. Additional visit to the Emergency room [ Time Frame: 28 days ]
    New attendance to the hospital due to worsening

  2. Need for hospitalization [ Time Frame: 28 days ]
    Hospitalization due to worsening

  3. Occurrence of adverse events [ Time Frame: 28 days ]
    Adverse reactions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult ≥18 years
  • Positive for SARS CoV-2
  • Radiological and clinical signs of mild-moderate pneumonia
  • Fever ≥37.7 ºC
  • Sat O2> 94% and respiratory rate <24 on admission
  • Able of taking oral medication
  • HIV negative
  • Written and signed consent

Exclusion Criteria:

  • Concomitant treatments with drugs of demonstrated or potential action against SARS CoV-2 within the previous 24 hours.
  • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 5 times the upper limit
  • corrected QT (QTc) interval prolongation> 450 msg,
  • Moderate or severe renal impairment (creatinine<50ml/min)
  • Severe hepatic impairment (Child-Pugh C)
  • Pregnancy or childbearing
  • Allergy to penicillin or any other beta-lactam
  • Primary carnitine deficiency
  • Malabsorption or swallowing problems
  • Inability to understand and follow study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709172


Contacts
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Contact: Mercedes Gimeno, Dr +34918870980 m.gimeno@meiji.es
Contact: Pilar Coronel Granado, Dr +34918870980 p.coronel@meiji.es

Locations
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Spain
HU Henares Recruiting
Coslada, Madrid, Spain, 28822
Contact: Cristóbal Rodríguez Leal, Dr    +34 638033338    cristobalmrl@gmail.com   
Sponsors and Collaborators
Meiji Pharma Spain S.A.
Investigators
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Principal Investigator: Cristóbal Rodríguez Leal, Dr HU Henares
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Responsible Party: Meiji Pharma Spain S.A.
ClinicalTrials.gov Identifier: NCT04709172    
Other Study ID Numbers: MPS-ME1207/401
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meiji Pharma Spain S.A.:
COVID-19
pneumonia
cefditoren
outpatient
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cefditoren
Cefditoren pivoxil
Anti-Bacterial Agents
Anti-Infective Agents