Solithromycin

DRUG12 trials

Sponsors

Ando Naokatsu, Melinta Therapeutics, Inc., National Institute of Allergy and Infectious Diseases (NIAID), Imperial College London

Conditions

Bacterial InfectionBacterial InfectionsCommunity-acquired Bacterial PneumoniaGonorrhoeaMycoplasma genitalium infection Mycoplasma genitaliumMycoplasma genitalium infecton Cervicitis, Urethritis, Proctitis, Sexually transmitted infection, Mycoplasma genitalium, SolithromycinNonalcoholic SteatohepatitisPulmonary Disease, Chronic Obstructive

Phase 1

Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

CompletedNCT01966055

Melinta Therapeutics, Inc.Bacterial Infections

Start: 2013-12-31End: 2014-09-30Updated: 2017-02-23

Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

CompletedNCT02268279

Melinta Therapeutics, Inc.Bacterial Infection

Start: 2015-01-31End: 2016-10-31Updated: 2017-06-09

Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

CompletedNCT02348424

National Institute of Allergy and Infectious Diseases (NIAID)Gonorrhoea

Start: 2015-05-05End: 2017-01-13Updated: 2019-01-28

Phase 2

Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea

CompletedNCT01591447

Melinta Therapeutics, Inc.Uncomplicated Urogenital Gonorrhea

Start: 2012-05-31End: 2013-06-30Updated: 2017-03-03

Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

CompletedNCT02510599

Melinta Therapeutics, Inc.Nonalcoholic Steatohepatitis

Start: 2015-12-31End: 2017-02-28Updated: 2017-03-21

Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia

TerminatedNCT02605122

Melinta Therapeutics, Inc.Community-acquired Bacterial Pneumonia

Start: 2016-04-30End: 2018-03-21Updated: 2019-01-03

A Study to Evaluate the Anti-inflammatory Effects of Solithromycin in Chronic Obstructive Pulmonary Disease

TerminatedNCT02628769

Imperial College LondonPulmonary Disease, Chronic Obstructive

Start: 2015-07-31End: 2017-01-05Updated: 2019-12-30

Placebo-controlled, double-blind, exploratory Phase 2 study of solithromycin in patients with Mycoplasma genitalium infection

RecruitingJPRN-jRCT2031250109

Ando NaokatsuMycoplasma genitalium infection Mycoplasma genitalium

Start: 2025-07-14Target: 45Updated: 2026-06-29

Exploratory Study of Solithromycin in Female Patients with Mycoplasma genitalium Infection

RecruitingJPRN-jRCTs031250792

Ando NaokatsuMycoplasma genitalium infecton Cervicitis, Urethritis, Proctitis, Sexually transmitted infection, Mycoplasma genitalium, Solithromycin

Start: 2026-03-11Target: 26Updated: 2026-06-29

Phase 3

Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

CompletedNCT01756339

Melinta Therapeutics, Inc.Community-acquired Bacterial Pneumonia

Start: 2012-12-31End: 2014-10-31Updated: 2017-03-03

Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia

CompletedNCT01968733

Melinta Therapeutics, Inc.Community-acquired Bacterial Pneumonia

Start: 2013-11-30End: 2015-09-30Updated: 2017-03-03

Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea

CompletedNCT02210325

Melinta Therapeutics, Inc.Uncomplicated Urogenital Gonorrhea

Start: 2014-08-31End: 2017-02-22Updated: 2017-09-11

Related Papers

Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents

UNC Libraries2020-04-15

A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication

Therapeutic Drug Monitoring2019-07-182 citations

Solithromycin versus ceftriaxone plus azithromycin for the treatment of uncomplicated genital gonorrhoea (SOLITAIRE-U): a randomised phase 3 non-inferiority trial.

2019-06-1049 citations

Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents

Antimicrobial Agents and Chemotherapy2018-06-115 citations

Treatment efficacy of azithromycin 1 g single dose versus doxycycline 100 mg twice daily for 7 days for the treatment of rectal chlamydia among men who have sex with men - a double-blind randomised controlled trial protocol.

2017-01-0613 citations

SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial Pneumonia

Clinical Infectious Diseases2016-07-2271 citations

Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents

Antimicrobial Agents and Chemotherapy2016-02-1715 citations

A Phase 2 Trial of Oral Solithromycin 1200 mg or 1000 mg as Single-Dose Oral Therapy for Uncomplicated Gonorrhea

Clinical Infectious Diseases2015-06-1862 citations