Trial · NCT02605122

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

NCT02605122, Phase 2, Phase 3, Terminated, Melinta Therapeutics, Inc.; results first posted 2019-01-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia. Trials, record NCT02605122. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02605122

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia
NCT number: NCT02605122
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 97 participants, actual
Lead sponsor: Melinta Therapeutics, Inc.
Conditions: Community-acquired Bacterial Pneumonia
Interventions: Solithromycin, Standard of Care
First posted: 2015-11-16
Last updated: 2019-01-03
Results first posted: 2019-01-03
Limitations and caveats: The study was discontinued early due to a company business decision. Study discontinuation was not related to safety or tolerability.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overview of Adverse Events By Treatment Arm	Up to 28 days post-treatment	Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization)
Secondary	Summary of Early Clinical Response	During Treatment Days 3 to 4	Early clinical response (ECR) was defined using the latest efficacy evaluation from Day 2 (if subject discharged prior to Day 2), Day3, or Day 4, and was defined as improvement in at least 1 presenting sign/symptom of CABP with no deterioration in any signs/symptoms of CABP and no requirement for an additional antibiotic.
Secondary	Summary of Clinical Improvement	Last day of Treatment (+48 hours)	Clinical improvement was assessed using the latest efficacy evaluation conducted on last day of treatment (+48 hours), and was defined identically to the early clinical response.
Secondary	Summary of Clinical Cure	Short-term follow-up at 16 days (+/- 4 days)	Clinical cure was assessed using the latest efficacy evaluation conducted on Day 16 (+/- 4 days) post-randomization, and was defined as resolution of all presenting signs/symptoms of CABP (excluding cough), no development of new signs/symptoms of CABP, and no requirement for an additional antibiotic.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overview of Adverse Events By Treatment Arm	Up to 28 days post-treatment	Treatment through Day 28 (28 days +/- 4days after randomization)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Summary of Early Clinical Response	During Treatment Days 3 to 4	Not all subjects had the Early Clinical Improvement assessment performed.	percentage of participants	NUMBER
SECONDARY	Summary of Clinical Improvement	Last day of Treatment (+48 hours)	Not all subjects had the Clinical Improvement assessment performed.	percentage of participants	NUMBER
SECONDARY	Summary of Clinical Cure	Short-term follow-up at 16 days (+/- 4 days)	Not all subjects had the Clinical cure assessment performed.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overview of Adverse Events By Treatment Arm	Solithromycin	TEAE	24		Participants
Overview of Adverse Events By Treatment Arm	Standard of Care	TEAE	7		Participants
Overview of Adverse Events By Treatment Arm	Solithromycin	TESAE	1		Participants
Overview of Adverse Events By Treatment Arm	Standard of Care	TESAE	1		Participants
Summary of Early Clinical Response	Solithromycin		66.7	95% Confidence Interval 52 to 79	percentage of participants
Summary of Early Clinical Response	Standard of Care		46.7	95% Confidence Interval 21 to 73	percentage of participants
Summary of Clinical Improvement	Solithromycin		64.5	95% Confidence Interval 51 to 76	percentage of participants
Summary of Clinical Improvement	Standard of Care		81	95% Confidence Interval 58 to 95	percentage of participants
Summary of Clinical Cure	Solithromycin		60.0	95% Confidence Interval 47 to 72	percentage of participants
Summary of Clinical Cure	Standard of Care		68.4	95% Confidence Interval 43 to 87	percentage of participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Solithromycin	73
Overall Study	STARTED	Standard of Care	24
Overall Study	Received Study Drug	Solithromycin	70
Overall Study	Received Study Drug	Standard of Care	24
Overall Study	COMPLETED	Solithromycin	68
Overall Study	COMPLETED	Standard of Care	22
Overall Study	NOT COMPLETED	Solithromycin	5
Overall Study	NOT COMPLETED	Standard of Care	2

Source ClinicalTrials.gov

Adverse events62

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Phlebitis	Vascular disorders	Solithromycin	5	70	5
other	Phlebitis	Vascular disorders	Standard of Care	0	24	0
other	Alanine Aminotransferase Increased	Investigations	Solithromycin	3	70	3
other	Alanine Aminotransferase Increased	Investigations	Standard of Care	0	24	0
other	Hepatic Enzyme Increased	Investigations	Solithromycin	1	70	1
other	Hepatic Enzyme Increased	Investigations	Standard of Care	0	24	0
other	Oxygen Saturation Decreased	Investigations	Solithromycin	1	70	1
other	Oxygen Saturation Decreased	Investigations	Standard of Care	0	24	0
other	Transaminases Increased	Investigations	Solithromycin	1	70	1
other	Transaminases Increased	Investigations	Standard of Care	0	24	0

1 to 10 of 62Source ClinicalTrials.gov

See all 62 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Solithromycin	0	70
Total, all-cause mortality	Standard of Care	0	24
Total, other adverse events	Solithromycin	24	70
Total, other adverse events	Standard of Care	7	24
Total, serious adverse events	Solithromycin	1	70
Total, serious adverse events	Standard of Care	1	24

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Solithromycin vs Standard of Care: deaths from any cause	Trial comparisons
Solithromycin vs Standard of Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02605122

GET https://conductscience.org/api/trials/v1/NCT02605122/events?page=2

API reference For AI assistants