Page last updated: 2024-11-11

cefditoren

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

cefditoren: structure given in first source; RN given refers to the (6R-(3(Z),6alpha,7beta(Z)))-isomer [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

cefditoren : A broad spectrum, third-generation cephalosporin antibiotic with (Z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl and (2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido groups at positions 3 and 7, respectively, of the cephem skeleton. Generally administered as its orally absorbed pivaloyloxymethyl ester prodrug, it is used for the treatment of mild to moderate infections caused by susceptible strains of microorganisms in acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, pharyngitis/tonsillitis, and uncomplicated skin and skin-structure infections. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID9870843
CHEMBL ID1743
CHEBI ID59343
SCHEMBL ID37473
MeSH IDM0198635

Synonyms (37)

Synonym
7beta-(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido-3-[(z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-3,4-didehydrocepham-4-carboxylic acid
(6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino}-3-[(z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
chebi:59343 ,
D07639
cefditoren (inn)
104145-95-1
cdtr
cefditoren
DB01066
5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino-3-(2-(4-methyl-5-thiazolyl)ethenyl)-8-oxo-, (6r-(3(z),6alpha,7beta(z)))-
(+)-(6r,7r)-7-(2-(2-amino-4-thiazolyl)glyoxylamido)-3-((z)-2-(4-methyl-5-thiazolyl)vinyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7(sup 2)-(z)-(o-methyloxime)
cefditoren [usan:inn]
(6r-(3(z),6alpha,7beta(z)))-7-((2-amino-4-thiazolyl)(methoxyimino)acetyl)amino-3-(2-(4-methyl-5-thiazolyl)ethenyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid
CHEMBL1743
C-2467
81qs09v3yw ,
unii-81qs09v3yw
cefditoren [vandf]
cefditoren [who-dd]
cefditoren [inn]
cefditoren [mi]
SCHEMBL37473
cefditorene, antibiotic for culture media use only
5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid, 7-(((2z)-2-(2-amino-4-thiazolyl)-2-(methoxyimino)-1-oxoethyl)amino)-3-((z)-2-(4-methyl-5-thiazolyl)ethenyl)-8-oxo-, (6r,7r)-
(6r,7r)-7-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido]-3-[(z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
C21546
(6r,7r)-7-[[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
DTXSID501328012
EN300-21702526
(6r,7r)-7-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido]-3-[(1z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
PD194305
cefditorene
7beta-(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido-3-((z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl)-3,4-didehydrocepham-4-carboxylic acid
cefditorenum
(6r,7r)-7-(((2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl)amino)-3-((z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl)-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic acid
j01dd16
cefditoreno

Research Excerpts

Overview

Cefditoren pivoxil is a third-generation oral cephalosporin with extended spectrum against Gram-negative, Gram-positive, and several anaerobic microorganisms. It has broad-spectrum antibacterial activity, including activity against those pathogens commonly causing OM.

ExcerptReferenceRelevance
"Cefditoren is an oral third-generation cephalosporin with a large spectrum activity against Gram-negative and Gram-positive bacteria which are reported to be responsible for respiratory tract and skin and skin structure infections. "( Cefditoren: a clinical overview.
Acquasanta, A; Flammini, S; Giuliano, S; Martini, L; Sbrana, F; Tascini, C, 2023
)
3.8
"Cefditoren pivoxil is a third-generation oral cephalosporin with extended spectrum against Gram-negative, Gram-positive, and several anaerobic microorganisms, including those frequently implicated in skin and soft tissue infections (SSTI). "( [Role of cefditoren in the treatment of community skin and soft tissue infections: revisiting the evidence].
Cabañero-Navalón, MD; García-Bustos, V; Salavert Lletí, M, 2021
)
2.48
"Cefditoren is a third-generation cephalosporin with broad-spectrum antibacterial activity, including activity against those pathogens commonly causing OM, with enhanced stability against common β-lactamases."( In vitro Activity of Cefditoren against Middle Ear Fluid Isolates from Costa Rican Children with Otitis Media.
Abdelnour, A; Arguedas, A; Guevara, S; Soley, C; Ulloa, C, 2014
)
1.44
"Cefditoren is a third-generation cephalosporin developed by Meiji Seika Kaisha Ltd. "( PEPT1 involved in the uptake and transepithelial transport of cefditoren in vivo and in vitro.
Liu, K; Liu, Q; Ma, X; Peng, J; Wang, C; Wu, J; Zhang, Q, 2009
)
2.04
"Cefditoren is a third-generation oral cephalosporin with good activity against respiratory tract pathogens, including penicillin-intermediate and -resistant strains of S. "( [Cefditoren and community-acquired lower respiratory tract infections (corrected)].
Barberán, J; Mensa, J, 2009
)
2.71
"Cefditoren is a third-generation orally administered cephalosporin with a broad spectrum of activity against Gram-positive and Gram-negative bacterial species. "( Comparative in vitro activity of cefditoren and other antimicrobials against Enterobacteriaceae causing community-acquired uncomplicated urinary tract infections in women: a Spanish nationwide multicenter study.
Bouza, E; Cercenado, E; Coronel, P; Cuevas, O; Gimeno, M; Marín, M, 2010
)
2.08
"Cefditoren is a broad-spectrum, oral cephalosporin that is highly active against clinically relevant respiratory tract pathogens, including multidrug-resistant Streptococcus pneumoniae. "( Use of population pharmacokinetic modeling and Monte Carlo simulation to describe the pharmacodynamic profile of cefditoren in plasma and epithelial lining fluid.
Bulitta, J; Drusano, GL; Hinder, M; Kinzig-Schippers, M; Lodise, TP; Loos, U; Sörgel, F; Vogel, F, 2008
)
2
"Cefditoren (ME 1206) is a new cephalosporin available for oral administration as the pivaloyloxymethyl ester (ME 1207). "( An in vitro characterization of cefditoren, a new oral cephalosporin.
Bhogal, H; Clark, S; Dencer, CA; Felmingham, D; Ghosh, G; Grüneberg, RN; Leakey, A; Mehta, MD; Ridgway, GL; Robbins, MJ, 1994
)
2.01
"Cefditoren appears to be a very promising beta-lactam possessing the greatest potency and potential spectrum versus contemporary (1997) respiratory tract pathogens."( In vitro evaluation of a novel orally administered cephalosporin (Cefditoren) tested against 1249 recent clinical isolates of Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae.
Barrett, MS; Biedenbach, DJ; Croco, MA; Jones, RN, 1998
)
1.26
"Cefditoren was observed to be a very active cephalosporin ranking among the most potent available orally active beta-lactams for use against a wide variety of pathogens."( Cefditoren activity against nearly 1000 non-fastidious bacterial isolates and the development of in vitro susceptibility test methods.
Biedenbach, DJ; Johnson, DM; Jones, RN, 2000
)
2.47
"Cefditoren is an advanced-generation, broad-spectrum cephalosporin antibiotic approved for the treatment of acute bacterial exacerbation of chronic bronchitis (AECB), group A beta-hemolytic streptococcal pharyngotonsillitis, and uncomplicated skin/skin structure infections in adult and adolescent patients."( Review of cefditoren, an advanced-generation, broad-spectrum oral cephalosporin.
Guay, DR, 2001
)
2.16
"Cefditoren is a novel broad-spectrum oral cephalosporin. "( Activity of cefditoren against beta-lactamase-positive and -negative Haemophilus influenzae and Moraxella catarrhalis.
Critchley, IA; Draghi, DC; Jones, ME; Karlowsky, JA; Sahm, DF; Thornsberry, C, 2002
)
2.14

Effects

ExcerptReferenceRelevance
"Cefditoren has a broad spectrum of activity against many gram-negative and gram-positive aerobes, including Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes, Haemophilus influenzae, and Moraxella catarrhalis. "( Review of cefditoren, an advanced-generation, broad-spectrum oral cephalosporin.
Guay, DR, 2001
)
2.16
"Cefditoren has been associated with high rates of bacteriologic response among the main causative pathogens in lower respiratory tract infection ( approximately 85% against H."( [Cefditoren and community-acquired lower respiratory tract infections (corrected)].
Barberán, J; Mensa, J, 2009
)
1.98

Toxicity

ExcerptReferenceRelevance
" It is important to review the adverse events profile related to antibiotic exposure during the clinical development of drugs that are or have been recently included in the therapeutic armamentarium."( Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections.
Aguilar, L; Coronel, P; Gimenez, MJ; Gimeno, M; Granizo, JJ; Prieto, J, 2009
)
0.69
" Adverse events considered by investigators as related during antibiotic exposure were considered."( Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections.
Aguilar, L; Coronel, P; Gimenez, MJ; Gimeno, M; Granizo, JJ; Prieto, J, 2009
)
0.69
"This study analysing reported adverse events from clinical trials showed an adverse events profile of cefditoren similar to those of standard antibiotics used in the treatment of respiratory tract infections."( Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections.
Aguilar, L; Coronel, P; Gimenez, MJ; Gimeno, M; Granizo, JJ; Prieto, J, 2009
)
0.9

Pharmacokinetics

The study was aimed at investigating the pharmacokinetic changes of cefdinir and cefditoren in AKI rats. The results of this study suggest that, from the pharmacodynamic per centiles of protein binding, cefuroxime may be more effective than amoxicillin/clavulanic acid.

ExcerptReferenceRelevance
" From the pharmacodynamic perspective, BSAC breakpoints seem more adequate to define or detect BLNAR strains."( Are beta-lactam breakpoints adequate to define non-susceptibility for all Haemophilus influenzae resistance phenotypes from a pharmacodynamic point of view?
Aguilar, L; Alou, L; Coronel, P; Echeverría, O; Giménez, MJ; González, N; Prieto, J; Sevillano, D; Torrico, M, 2007
)
0.34
" This study described its pharmacodynamic profile in plasma and epithelial lining fluid (ELF)."( Use of population pharmacokinetic modeling and Monte Carlo simulation to describe the pharmacodynamic profile of cefditoren in plasma and epithelial lining fluid.
Bulitta, J; Drusano, GL; Hinder, M; Kinzig-Schippers, M; Lodise, TP; Loos, U; Sörgel, F; Vogel, F, 2008
)
0.56
"The objectives of this randomized, double-blind study were to evaluate the pharmacokinetics, and the pharmacodynamic and gastrointestinal (GI) tolerance of cefditoren pivoxil in healthy adult male volunteers when it is administered three times a day."( Pharmacokinetic/pharmacodynamic serum and urine profile of cefditoren following single-dose and multiple twice- and thrice-daily regimens in healthy volunteers: a phase I study.
Azanza, JR; Campanero, MA; Coronel, P; Gimeno, M; Honorato, J; Quetglas, EG; Sádaba, B, 2007
)
0.78
"The results of this study suggest that, from the pharmacodynamic perspective, the presence of physiological albumin concentrations may not preclude antipneumococcal activity of highly bound cephalosporins as cefditoren."( High protein binding and cidal activity against penicillin-resistant S. pneumoniae: a cefditoren in vitro pharmacodynamic simulation.
Aguilar, L; Alou, L; Cafini, F; Coronel, P; Fenoll, A; Giménez, MJ; González, N; Prieto, J; Sevillano, D; Torrico, M, 2008
)
0.76
" A computerized pharmacodynamic model simulating free antibiotic concentrations (calculated considering reported percentages of protein binding) of 400 mg twice-daily cefditoren, 500 mg twice-daily cefuroxime and 875/125 mg three times daily amoxicillin/clavulanic acid was used to explore antibacterial activity against initial mixed inocula with 25% of each strain."( Influence of different resistance traits on the competitive growth of Haemophilus influenzae in antibiotic-free medium and selection of resistant populations by different {beta}-lactams: an in vitro pharmacodynamic approach.
Aguilar, L; Alou, L; Cafini, F; Coronel, P; Giménez, MJ; González, N; Prieto, J; Sevillano, D; Torrico, M, 2009
)
0.55
"Population pharmacokinetic analysis was conducted on cefditoren pivoxil (CDTR-PI), a third generation oral antibiotic to evaluate the effect of covariates on pharmacokinetic parameters."( Population pharmacokinetics of cefditoren pivoxil in non-infected adults.
Matsumoto, K; Mitomi, N; Sato, N; Shibasaki, S; Shitara, Y, 2014
)
0.94
" This study was aimed at investigating the pharmacokinetic changes of cefdinir and cefditoren in AKI rats, and elucidating the possible molecular mechanisms."( Pharmacokinetic changes of cefdinir and cefditoren and its molecular mechanisms in acute kidney injury in rats.
Huo, X; Liu, K; Liu, Z; Ma, X; Meng, Q; Peng, J; Sun, H; Sun, P; Wang, C; Wang, H, 2018
)
0.97
" On this basis, the pharmacokinetic changes of cefdinir and cefditoren were investigated in normal and AKI rats."( Pharmacokinetic changes of cefdinir and cefditoren and its molecular mechanisms in acute kidney injury in rats.
Huo, X; Liu, K; Liu, Z; Ma, X; Meng, Q; Peng, J; Sun, H; Sun, P; Wang, C; Wang, H, 2018
)
0.99
" However, the pharmacokinetic changes of cefditoren were not observed."( Pharmacokinetic changes of cefdinir and cefditoren and its molecular mechanisms in acute kidney injury in rats.
Huo, X; Liu, K; Liu, Z; Ma, X; Meng, Q; Peng, J; Sun, H; Sun, P; Wang, C; Wang, H, 2018
)
1.01

Bioavailability

ExcerptReferenceRelevance
" The absorption rate constant (ka: hr(-1)) of CDTR-PI decreased with age, total clearance adjusted by bioavailability (CL/F: L/hr/kg) increased with increasing creatinine clearance adjusted by body weight (Ccr: mL/min/kg) and volume of distribution adjusted by bioavailability (Vd/F: L/kg) decreased with increasing body weight (WT: kg)."( Population pharmacokinetics of cefditoren pivoxil in non-infected adults.
Matsumoto, K; Mitomi, N; Sato, N; Shibasaki, S; Shitara, Y, 2014
)
0.69
" In fasting patients oral bioavailability is low and increases when the drug is taken with food."( Cefditoren: a clinical overview.
Acquasanta, A; Flammini, S; Giuliano, S; Martini, L; Sbrana, F; Tascini, C, 2023
)
2.35

Dosage Studied

Monte Carlo simulation (9,999 subjects) was performed with the ADAPT II program to estimate the probability of target attainment at which the free-cefditoren plasma concentrations (88%) protein binding and total ELF concentrations exceeded the MIC. The experimental bactericidal activity of cefditoren is maintained over the dosing interval regardless of the presence of a mutation in the ftsI gene.

ExcerptRelevanceReference
"6 microg/ml, respectively with 200 or 400 mg doses of cefditoren pivoxil; plasma concentrations exceed 1 microg/ml for 4 to 6 hours (33-50% of dosing interval)."( Antimicrobial activity and in vitro susceptibility test development for cefditoren against Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus species.
Beach, ML; Biedenbach, DJ; Johnson, DM; Jones, RN; Pfaller, MA, 2000
)
0.79
" The experimental bactericidal activity of cefditoren is maintained over the dosing interval regardless of the presence of a mutation in the ftsI gene or beta-lactamase production."( influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
Aguilar, L; Alou, L; Cafini, F; Coronel, P; Echeverría, O; Giménez, MJ; González, N; Prieto, J; Sevillano, D; Torrico, M, 2007
)
0.81
" The cumulative percentage of a 24h-period that drug concentrations exceeded the MIC for total (T > MIC) and unbound concentrations (fT > MIC), expressed as percentage of the dosing interval, were determined."( High protein binding and cidal activity against penicillin-resistant S. pneumoniae: a cefditoren in vitro pharmacodynamic simulation.
Aguilar, L; Alou, L; Cafini, F; Coronel, P; Fenoll, A; Giménez, MJ; González, N; Prieto, J; Sevillano, D; Torrico, M, 2008
)
0.57
" CDN was bactericidal (percentage of the dosing interval for which experimental antibiotic concentrations exceeded the MIC [ft>MIC], >88%), and no recombined populations were detected from 4 h on."( Efficacy of simulated cefditoren versus amoxicillin-clavulanate free concentrations in countering intrastrain ftsI gene diffusion in Haemophilus influenzae.
Aguilar, L; Alou, L; Cafini, F; Coronel, P; Giménez, MJ; González, N; López, AM; Prieto, J; Sevillano, D; Torrico, M, 2011
)
0.68
" Similarly to other beta-lactams, cefditoren is a time-dependent antibiotic, and its "best" PK/PD target is probably 40% dosing interval time > 4- 5-fold MIC and 40-70% dosing interval time > 4- 5-fold MIC for bacteriostatic and bactericidal effect, respectively."( Cefditoren: a clinical overview.
Acquasanta, A; Flammini, S; Giuliano, S; Martini, L; Sbrana, F; Tascini, C, 2023
)
2.63
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
antibacterial drugA drug used to treat or prevent bacterial infections.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
cephalosporinA class of beta-lactam antibiotics differing from the penicillins in having a 6-membered, rather than a 5-membered, side ring. Although cephalosporins are among the most commonly used antibiotics in the treatment of routine infections, and their use is increasing over time, they can cause a range of hypersensitivity reactions, from mild, delayed-onset cutaneous reactions to life-threatening anaphylaxis in patients with immunoglobulin E (IgE)-mediated allergy.
carboxylic acidA carbon oxoacid acid carrying at least one -C(=O)OH group and having the structure RC(=O)OH, where R is any any monovalent functional group. Carboxylic acids are the most common type of organic acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Bioassays (2)

Assay IDTitleYearJournalArticle
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (116)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's11 (9.48)18.2507
2000's72 (62.07)29.6817
2010's24 (20.69)24.3611
2020's9 (7.76)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 72.70

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index72.70 (24.57)
Research Supply Index4.91 (2.92)
Research Growth Index4.84 (4.65)
Search Engine Demand Index123.72 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (72.70)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials10 (8.06%)5.53%
Reviews14 (11.29%)6.00%
Case Studies5 (4.03%)4.05%
Observational0 (0.00%)0.25%
Other95 (76.61%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Multicentre, Prospective, Comparative, Randomized, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of Cefditoren Pivoxil vs. Ciprofloxacin in Uncomplicated Acute Cystitis [NCT00598403]Phase 3611 participants (Actual)Interventional2007-11-30Completed
A Comparison of Cefditoren Pivoxil 10 mg/kg/Day and Cefditoren Pivoxil 20 mg/kg/Day in Treatment of Childhood With Acute Rhinosinusitis [NCT01553006]Phase 4120 participants (Anticipated)Interventional2012-01-31Recruiting
Prospective, Non-controlled Pilot Study to Evaluate the Efficacy and Safety of Cefditoren Pivoxil in COVID-19 Patients With Mild to Moderate Pneumonia [NCT04709172]Phase 420 participants (Actual)Interventional2021-01-05Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]