Page last updated: 2024-11-01

ofloxacin and Cystic Fibrosis

ofloxacin has been researched along with Cystic Fibrosis in 27 studies

Ofloxacin: A synthetic fluoroquinolone antibacterial agent that inhibits the supercoiling activity of bacterial DNA GYRASE, halting DNA REPLICATION.
9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid : An oxazinoquinoline that is 2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinolin-7-one substituted by methyl, carboxy, fluoro, and 4-methylpiperazin-1-yl groups at positions 3, 6, 9, and 10, respectively.
ofloxacin : A racemate comprising equimolar amounts of levofloxacin and dextrofloxacin. It is a synthetic fluoroquinolone antibacterial agent which inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication.

Cystic Fibrosis: An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.

Research Excerpts

ExcerptRelevanceReference
"The pharmacokinetics and tolerability of nebulized MP-376 (levofloxacin inhalation solution [Aeroquin]) were determined in cystic fibrosis (CF) subjects."9.15Pharmacokinetics and safety of MP-376 (levofloxacin inhalation solution) in cystic fibrosis subjects. ( Dudley, MN; Flume, PA; Geller, DE; Griffith, DC; Loutit, JS; Morgan, E; White, D, 2011)
"Levofloxacin is used in adult patients with cystic fibrosis but its pharmacokinetics is not well characterized in this population."9.12Altered steady state pharmacokinetics of levofloxacin in adult cystic fibrosis patients receiving calcium carbonate. ( Allen, SE; Amsden, GW; Pai, MP, 2006)
"The steady state pharmacokinetic properties of ciprofloxacin and ofloxacin were compared in cystic fibrosis patients."9.06Comparative pharmacokinetics of ciprofloxacin and ofloxacin in cystic fibrosis patients. ( Hvidberg, EF; Jensen, T; Pedersen, SS, 1987)
"The clinical efficacy and safety of ciprofloxacin and ofloxacin were compared in a prospective, randomized double blind, placebo combined cross-over study in 26 adult cystic fibrosis patients with chronic broncho-pulmonary Pseudomonas aeruginosa infection."9.06The efficacy and safety of ciprofloxacin and ofloxacin in chronic Pseudomonas aeruginosa infection in cystic fibrosis. ( Høiby, N; Jensen, T; Koch, C; Nielsen, CH; Pedersen, SS, 1987)
"Levofloxacin is a fluoroquinolone with extensive renal elimination and enhanced penetration into lungs and Pseudomonas aeruginosa (PA) biofilms."6.73Levofloxacin pharmacokinetics in adult cystic fibrosis. ( Boyle, MP; Brass-Ernst, L; Diener-West, M; Lee, CKK; Noschese, M; Zeitlin, PL, 2007)
"Levofloxacin was the most potent antibiotic against all cystic fibrosis isolates tested, with MIC(90)s ranging from 8 to 32 microg/ml."5.36In vitro pharmacodynamics of levofloxacin and other aerosolized antibiotics under multiple conditions relevant to chronic pulmonary infection in cystic fibrosis. ( Burns, JL; Dudley, MN; Griffith, DC; King, P; Lomovskaya, O, 2010)
"The pharmacokinetics and tolerability of nebulized MP-376 (levofloxacin inhalation solution [Aeroquin]) were determined in cystic fibrosis (CF) subjects."5.15Pharmacokinetics and safety of MP-376 (levofloxacin inhalation solution) in cystic fibrosis subjects. ( Dudley, MN; Flume, PA; Geller, DE; Griffith, DC; Loutit, JS; Morgan, E; White, D, 2011)
"Levofloxacin is used in adult patients with cystic fibrosis but its pharmacokinetics is not well characterized in this population."5.12Altered steady state pharmacokinetics of levofloxacin in adult cystic fibrosis patients receiving calcium carbonate. ( Allen, SE; Amsden, GW; Pai, MP, 2006)
"The steady state pharmacokinetic properties of ciprofloxacin and ofloxacin were compared in cystic fibrosis patients."5.06Comparative pharmacokinetics of ciprofloxacin and ofloxacin in cystic fibrosis patients. ( Hvidberg, EF; Jensen, T; Pedersen, SS, 1987)
"The clinical efficacy and safety of ciprofloxacin and ofloxacin were compared in a prospective, randomized double blind, placebo combined cross-over study in 26 adult cystic fibrosis patients with chronic broncho-pulmonary Pseudomonas aeruginosa infection."5.06The efficacy and safety of ciprofloxacin and ofloxacin in chronic Pseudomonas aeruginosa infection in cystic fibrosis. ( Høiby, N; Jensen, T; Koch, C; Nielsen, CH; Pedersen, SS, 1987)
"Levofloxacin is a fluoroquinolone with extensive renal elimination and enhanced penetration into lungs and Pseudomonas aeruginosa (PA) biofilms."2.73Levofloxacin pharmacokinetics in adult cystic fibrosis. ( Boyle, MP; Brass-Ernst, L; Diener-West, M; Lee, CKK; Noschese, M; Zeitlin, PL, 2007)
"The treatment with ofloxacin in accordance with the above scheme resulted in a rapid improvement of the patient state: the intoxication lowered, the expectoration and the sputum viscosity decreased, the body temperature normalized by the 5th day."2.68[An attempt to use ofloxacin in patients with mucoviscidosis]. ( Apul'tsina, ID; Chuchalin, AG; GUgutsidze, EN; Kuchkina, NV; Samsonova, MV; Sokolov, AS, 1996)
" Older literature supports an oral dosing regimen of 40 mg/kg/day divided every 12 hr, up to 2 g/day, and intravenous (IV) ciprofloxacin 30 mg/kg/day divided every 8 hr, maximum 1."2.49Optimization of anti-pseudomonal antibiotics for cystic fibrosis pulmonary exacerbations: III. fluoroquinolones. ( Ampofo, K; Sherwin, CM; Spigarelli, MG; Stockmann, C; Waters, CD; Young, DC; Zobell, JT, 2013)
"Levofloxacin was the most potent antibiotic against all cystic fibrosis isolates tested, with MIC(90)s ranging from 8 to 32 microg/ml."1.36In vitro pharmacodynamics of levofloxacin and other aerosolized antibiotics under multiple conditions relevant to chronic pulmonary infection in cystic fibrosis. ( Burns, JL; Dudley, MN; Griffith, DC; King, P; Lomovskaya, O, 2010)

Research

Studies (27)

TimeframeStudies, this research(%)All Research%
pre-19908 (29.63)18.7374
1990's4 (14.81)18.2507
2000's8 (29.63)29.6817
2010's7 (25.93)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Chung, WJ1
Goeckeler-Fried, JL1
Havasi, V1
Chiang, A1
Rowe, SM1
Plyler, ZE1
Hong, JS1
Mazur, M1
Piazza, GA1
Keeton, AB1
White, EL1
Rasmussen, L1
Weissman, AM1
Denny, RA1
Brodsky, JL1
Sorscher, EJ1
King, P2
Lomovskaya, O2
Griffith, DC3
Burns, JL1
Dudley, MN3
Citron, DM1
Geller, DE2
Flume, PA2
Morgan, E1
White, D1
Loutit, JS2
Staab, D1
Fischer, R1
Conrad, DJ1
Fernández-Olmos, A1
García-Castillo, M1
Maiz, L1
Lamas, A1
Baquero, F1
Cantón, R1
Stockmann, C1
Sherwin, CM1
Zobell, JT1
Young, DC1
Waters, CD1
Spigarelli, MG1
Ampofo, K1
Postnikov, SS2
Semykin, SIu1
Nazhimov, VP1
Novichkova, GA1
Golini, G1
Favari, F1
Marchetti, F1
Fontana, R1
McKnight, AJ1
Shaw, A1
Goldsmith, CE1
Clarke, L1
Millar, BC1
McCaughan, J1
Elborn, JS1
Reid, A1
Moore, JE1
Roveta, S1
Schito, AM1
Marchese, A1
Schito, GC1
Pai, MP1
Allen, SE1
Amsden, GW1
Lee, CKK1
Boyle, MP1
Diener-West, M1
Brass-Ernst, L1
Noschese, M1
Zeitlin, PL1
Høiby, N3
Pedersen, SS4
Jensen, T4
Valerius, NH1
Koch, C3
Upton, C1
Chuchalin, AG1
Sokolov, AS1
Apul'tsina, ID1
GUgutsidze, EN1
Kuchkina, NV1
Samsonova, MV1
Gillespie, T1
Masterton, RG1
Romano, L1
Girosi, D1
Spallone, E1
Parisi, F1
Minicucci, L1
Romano, C1
Croize, J1
Gout, JP1
Robert, J1
Le Noc, P1
Pertuiset, E1
Lenoir, G1
Jehanne, M1
Douchain, F1
Guillot, M1
Menkès, CJ1
Kurz, CC1
Marget, W1
Harms, K1
Bertele, RM1
Nielsen, B1
Nielsen, H1
Hvidberg, EF1
Nielsen, CH1
Meyer, H1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients[NCT00677365]Phase 2151 participants (Actual)Interventional2008-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change in FEV1 Percent Predicted

Change in the predicted percent of air the patient could exhale in one second (NCT00677365)
Timeframe: from baseline to the end of the treatment 28-day treatment period (28 days)

InterventionPercent (Least Squares Mean)
Placebo-2.39
MP-376 120 mg QD1.96
MP-376 240 mg QD3.10
MP-376 240 mg BID8.55

Change in P. Aeruginosa Density

Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period (NCT00677365)
Timeframe: from baseline to end of treatment (28 days)

Interventionlog10 CFU/g sputum (Least Squares Mean)
Placebo0.23
MP-376 120 mg QD-0.31
MP-376 240 mg QD-0.31
MP-376 240 mg BID-0.73

Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)

Change in the score from 0 to 100 that a patient reports for their respiratory symptoms in the CFQ-R. An increase in score illustrates an improvement in symptoms. An increase of 4 or more is considered clinically significant (NCT00677365)
Timeframe: from baseline to the end of the 28-day treatment period (28 days)

Interventionunits on a scale (Least Squares Mean)
Placebo-0.44
MP-376 120 mg QD2.00
MP-376 240 mg QD0.31
MP-376 240 mg BID4.06

Percent Change in Forced Expiratory Volume in 1 Second (FEV1)

Percent change in the amount of air the patient could exhale in 1 second (NCT00677365)
Timeframe: from baseline to end of the 28-day treatment period (28 days)

InterventionPercent change (Least Squares Mean)
Placebo-2.36
MP-376 120 mg QD1.93
MP-376 240 mg QD2.56
MP-376 240 mg BID6.25

Time to Administration of Other Anti-pseudomonal Antimicrobials

Time to administration of other anti-pseudomonal antimicrobials in patients with at least one of the following: decreased exercise tolerance, increased cough, increased sputum/chest congestion, or decreased appetite; 25th percentile data reported (NCT00677365)
Timeframe: from baseline until final study visit (up to 56 days)

Interventiondays (Mean)
Placebo31
MP-376 120 mg QDNA
MP-376 240 mg QD56
MP-376 240 mg BID59

Changes in Susceptability Patterns of Isolated Organisms

All isolates of P. aeruginosa cultures grown from patient sputum samples were evaluated to see whether the minimum concentration of levofloxacin needed to inhibit growth of the bacteria (i.e., minimum inhibitory concentration; MIC) had increased; 2. The MIC50 and MIC90 values were calculated as the 50th percentile value and the 90th percentile value, respectively. Note that percentile values between dilution values were rounded up to the nearest dilution value (NCT00677365)
Timeframe: from baseline until the end of the 28-day treatment period (28 days)

,,,
Interventionug/mL (Number)
Baseline Minimum Inhibitory Concentration (MIC)50Day 28 MIC for 50% (MIC50)Baseline MIC for 90% (MIC90)Day 28 MIC90
MP-376 120 mg QD443216
MP-376 240 mg BID441632
MP-376 240 mg QD441616
Placebo44168

Reviews

3 reviews available for ofloxacin and Cystic Fibrosis

ArticleYear
Optimization of anti-pseudomonal antibiotics for cystic fibrosis pulmonary exacerbations: III. fluoroquinolones.
    Pediatric pulmonology, 2013, Volume: 48, Issue:3

    Topics: Administration, Oral; Anti-Bacterial Agents; Ciprofloxacin; Cystic Fibrosis; Disease Progression; Dr

2013
Fluoroquinolones in the treatment of cystic fibrosis.
    Drugs, 1993, Volume: 45 Suppl 3

    Topics: Ciprofloxacin; Cystic Fibrosis; Drug Therapy, Combination; Humans; Ofloxacin; Pseudomonas Infections

1993
[Joint tolerance of pefloxacin and ofloxacin in children and adolescents with cystic fibrosis].
    Revue du rhumatisme et des maladies osteo-articulaires, 1989, Volume: 56, Issue:11

    Topics: Adolescent; Animals; Arthritis; Cartilage, Articular; Child; Cystic Fibrosis; Dogs; Female; Humans;

1989

Trials

11 trials available for ofloxacin and Cystic Fibrosis

ArticleYear
Pharmacokinetics and safety of MP-376 (levofloxacin inhalation solution) in cystic fibrosis subjects.
    Antimicrobial agents and chemotherapy, 2011, Volume: 55, Issue:6

    Topics: Administration, Inhalation; Adolescent; Adult; Anti-Bacterial Agents; Area Under Curve; Cross-Over S

2011
Levofloxacin inhalation solution (MP-376) in patients with cystic fibrosis with Pseudomonas aeruginosa.
    American journal of respiratory and critical care medicine, 2011, Jun-01, Volume: 183, Issue:11

    Topics: Administration, Inhalation; Adult; Anti-Bacterial Agents; Cystic Fibrosis; Dose-Response Relationshi

2011
[On fluoroquinolones treatment safety in children (clinical, morphological and catamnesis data)].
    Antibiotiki i khimioterapiia = Antibiotics and chemoterapy [sic], 2002, Volume: 47, Issue:9

    Topics: Adolescent; Age Factors; Anemia, Aplastic; Anti-Infective Agents; Body Height; Cartilage; Child; Chi

2002
Altered steady state pharmacokinetics of levofloxacin in adult cystic fibrosis patients receiving calcium carbonate.
    Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2006, Volume: 5, Issue:3

    Topics: Adolescent; Adult; Anti-Bacterial Agents; Biological Availability; Calcium Carbonate; Cations; Cross

2006
Levofloxacin pharmacokinetics in adult cystic fibrosis.
    Chest, 2007, Volume: 131, Issue:3

    Topics: Adolescent; Adult; Anti-Bacterial Agents; Cystic Fibrosis; Female; Humans; Kidney Function Tests; Le

2007
[An attempt to use ofloxacin in patients with mucoviscidosis].
    Antibiotiki i khimioterapiia = Antibiotics and chemoterapy [sic], 1996, Volume: 41, Issue:9

    Topics: Administration, Oral; Anti-Infective Agents; Cystic Fibrosis; Humans; Klebsiella; Microbial Sensitiv

1996
[The use of ofloxacin in cystic fibrosis patients].
    Minerva pediatrica, 1992, Volume: 44, Issue:3

    Topics: Adolescent; Adult; Analysis of Variance; Chronic Disease; Cystic Fibrosis; Drug Tolerance; Female; H

1992
[A cross-over study on the effectiveness of ofloxacin and ciprofloxacin administered orally].
    Infection, 1986, Volume: 14 Suppl 1

    Topics: Administration, Oral; Adolescent; Adult; Anti-Infective Agents; Ciprofloxacin; Clinical Trials as To

1986
Efficacy of oral fluoroquinolones versus conventional intravenous antipseudomonal chemotherapy in treatment of cystic fibrosis.
    European journal of clinical microbiology, 1987, Volume: 6, Issue:6

    Topics: Adult; Anti-Infective Agents; Chronic Disease; Ciprofloxacin; Clinical Trials as Topic; Cystic Fibro

1987
Comparative pharmacokinetics of ciprofloxacin and ofloxacin in cystic fibrosis patients.
    The Journal of antimicrobial chemotherapy, 1987, Volume: 20, Issue:4

    Topics: Adolescent; Adult; Anti-Infective Agents; Ciprofloxacin; Cystic Fibrosis; Double-Blind Method; Femal

1987
The efficacy and safety of ciprofloxacin and ofloxacin in chronic Pseudomonas aeruginosa infection in cystic fibrosis.
    The Journal of antimicrobial chemotherapy, 1987, Volume: 20, Issue:4

    Topics: Adolescent; Adult; Anti-Infective Agents; Ciprofloxacin; Cystic Fibrosis; Double-Blind Method; Drug

1987

Other Studies

13 other studies available for ofloxacin and Cystic Fibrosis

ArticleYear
Increasing the Endoplasmic Reticulum Pool of the F508del Allele of the Cystic Fibrosis Transmembrane Conductance Regulator Leads to Greater Folding Correction by Small Molecule Therapeutics.
    PloS one, 2016, Volume: 11, Issue:10

    Topics: Alleles; Benzoates; Cells, Cultured; Cystic Fibrosis; Cystic Fibrosis Transmembrane Conductance Regu

2016
In vitro pharmacodynamics of levofloxacin and other aerosolized antibiotics under multiple conditions relevant to chronic pulmonary infection in cystic fibrosis.
    Antimicrobial agents and chemotherapy, 2010, Volume: 54, Issue:1

    Topics: Aerosols; Anti-Bacterial Agents; Bacteria; Biofilms; Chronic Disease; Ciprofloxacin; Colony Count, M

2010
Effect of oxygen limitation on the in vitro activity of levofloxacin and other antibiotics administered by the aerosol route against Pseudomonas aeruginosa from cystic fibrosis patients.
    Diagnostic microbiology and infectious disease, 2010, Volume: 66, Issue:2

    Topics: Aerobiosis; Aerosols; Anaerobiosis; Anti-Bacterial Agents; Cystic Fibrosis; Humans; Levofloxacin; Mi

2010
In vitro prevention of Pseudomonas aeruginosa early biofilm formation with antibiotics used in cystic fibrosis patients.
    International journal of antimicrobial agents, 2012, Volume: 40, Issue:2

    Topics: Bacterial Typing Techniques; Biofilms; Ciprofloxacin; Cystic Fibrosis; Female; Humans; Levofloxacin;

2012
Bacteriostatic and bactericidal activity of levofloxacin against clinical isolates from cystic fibrosis patients.
    European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2004, Volume: 23, Issue:10

    Topics: Anti-Bacterial Agents; Burkholderia cepacia; Cystic Fibrosis; Drug Resistance, Bacterial; Haemophilu

2004
Comparison of in vitro susceptibilities to levofloxacin and ciprofloxacin with Pseudomonas aeruginosa and Stenotrophomonas maltophilia isolated from cystic fibrosis patients in Northern Ireland.
    British journal of biomedical science, 2005, Volume: 62, Issue:1

    Topics: Adult; Anti-Bacterial Agents; Anti-Infective Agents; Child; Ciprofloxacin; Cystic Fibrosis; Female;

2005
Microbiological rationale for the utilisation of prulifloxacin, a new fluoroquinolone, in the eradication of serious infections caused by Pseudomonas aeruginosa.
    International journal of antimicrobial agents, 2005, Volume: 26, Issue:5

    Topics: Anti-Bacterial Agents; Aza Compounds; Ciprofloxacin; Cystic Fibrosis; Dioxolanes; Drug Resistance, B

2005
Sleep disturbance in children treated with ofloxacin.
    BMJ (Clinical research ed.), 1994, Nov-26, Volume: 309, Issue:6966

    Topics: Child; Cystic Fibrosis; Female; Humans; Male; Ofloxacin; Opportunistic Infections; Pseudomonas Infec

1994
[Comparative efficacy and safety of ciprofloxacin, ofloxacin, and pefloxacin in treatment of respiratory infections in children with cystic fibrosis].
    Antibiotiki i khimioterapiia = Antibiotics and chemoterapy [sic], 2001, Volume: 46, Issue:3

    Topics: Adolescent; Anti-Infective Agents; Arthritis; Child; Child, Preschool; Ciprofloxacin; Cystic Fibrosi

2001
Investigation into the selection frequency of resistant mutants and the bacterial kill rate by levofloxacin and ciprofloxacin in non-mucoid Pseudomonas aeruginosa isolates from cystic fibrosis patients.
    International journal of antimicrobial agents, 2002, Volume: 19, Issue:5

    Topics: Adult; Anti-Infective Agents; Ciprofloxacin; Cystic Fibrosis; Dose-Response Relationship, Drug; Drug

2002
[In vitro effect of various antibiotics: beta lactams, aminoglycosides and fluoroquinolones alone and in combination against P. aeruginosa isolated from patients with mucoviscidosis].
    Pathologie-biologie, 1989, Volume: 37, Issue:5 Pt 2

    Topics: Aminoglycosides; Anti-Bacterial Agents; beta-Lactams; Ciprofloxacin; Cystic Fibrosis; Drug Resistanc

1989
Bactericidal effect of polymorphonuclear leukocytes on Pseudomonas aeruginosa pre-incubated in ofloxacin.
    Acta pathologica, microbiologica, et immunologica Scandinavica. Section B, Microbiology, 1987, Volume: 95, Issue:4

    Topics: Anti-Bacterial Agents; Blood Bactericidal Activity; Cystic Fibrosis; Humans; Kinetics; Neutrophils;

1987
Ofloxacin in cystic fibrosis.
    Drugs, 1987, Volume: 34 Suppl 1

    Topics: Adolescent; Adult; Anti-Infective Agents; Child; Child, Preschool; Cystic Fibrosis; Female; Humans;

1987