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Condition (MeSH)

Gram-Negative Bacterial Infections

ClinicalTrials.gov lists 1,847 trials for Gram-Negative Bacterial Infections or a narrower condition beneath it. GlaxoSmithKline has the most among industry and government lead sponsors, with 194.

MeSH D016905 Infections C01
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Phase 1 Phase 1 142 Phase 1/2 Phase 1/2 51 Phase 2 Phase 2 268 Phase 2/3 Phase 2/3 27 Phase 3 Phase 3 371 Phase 4 Phase 4 240 Not applicable Not applicable 288 Observational Observational 456 Phase 1 Phase 1 142 Phase 1/2 Phase 1/2 51 Phase 2 Phase 2 268 Phase 2/3 Phase 2/3 27 Phase 3 Phase 3 371 Phase 4 Phase 4 240 Not applicable Not applicable 288 Observational Observational 456

Trials per phase

2 more sections with rows

53 of the 1,847 trials are tagged with Gram-Negative Bacterial Infections itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Gram-Negative Bacterial Infections trials start? (33)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 3 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational
  • Other (Unknown)

Top of scale: 91

1991: 1 trials (Phase 3 1) 1992: 1 trials (Phase 3 1) 1996: 1 trials (Observational 1) 1997: 9 trials (Observational 2, Phase 4 1, Phase 3 5, Phase 2 1) 1998: 3 trials (Observational 2, Phase 2 1) 1999: 9 trials (Observational 1, Phase 3 4, Phase 2 4) 2000: 6 trials (Phase 4 1, Phase 3 3, Phase 2 1, Phase 1/2 1) 2001: 13 trials (Observational 3, Phase 4 6, Phase 3 3, Phase 1 1) 2002: 18 trials (Observational 2, Not applicable 3, Phase 4 3, Phase 3 6, Phase 2/3 1, Phase 2 3) 2003: 39 trials (Observational 4, Not applicable 4, Phase 4 7, Phase 3 8, Phase 2/3 2, Phase 2 12, Phase 1/2 1, Phase 1 1) 2004: 34 trials (Observational 4, Not applicable 4, Phase 4 7, Phase 3 8, Phase 2/3 1, Phase 2 7, Phase 1/2 1, Phase 1 2) 2005: 55 trials (Observational 11, Not applicable 2, Phase 4 7, Phase 3 17, Phase 2 16, Phase 1 2) 2006: 86 trials (Observational 14, Not applicable 6, Phase 4 10, Phase 3 39, Phase 2 12, Phase 1/2 1, Phase 1 4) 2007: 73 trials (Observational 13, Not applicable 8, Phase 4 9, Phase 3 29, Phase 2/3 1, Phase 2 9, Phase 1/2 2, Phase 1 2) 2008: 85 trials (Observational 18, Not applicable 2, Phase 4 15, Phase 3 21, Phase 2/3 1, Phase 2 17, Phase 1/2 5, Phase 1 6) 2009: 68 trials (Observational 16, Not applicable 9, Phase 4 4, Phase 3 19, Phase 2/3 1, Phase 2 12, Phase 1/2 1, Phase 1 6) 2010: 84 trials (Observational 9, Not applicable 9, Phase 4 9, Phase 3 24, Phase 2/3 1, Phase 2 23, Phase 1/2 3, Phase 1 6) 2011: 81 trials (Observational 15, Not applicable 8, Phase 4 17, Phase 3 20, Phase 2 14, Phase 1 7) 2012: 70 trials (Observational 17, Not applicable 11, Phase 4 11, Phase 3 15, Phase 2/3 2, Phase 2 7, Phase 1/2 1, Phase 1 6) 2013: 76 trials (Observational 16, Not applicable 19, Phase 4 8, Phase 3 17, Phase 2 8, Phase 1/2 1, Phase 1 7) 2014: 82 trials (Observational 21, Not applicable 11, Phase 4 8, Phase 3 23, Phase 2/3 3, Phase 2 9, Phase 1 7) 2015: 64 trials (Observational 19, Not applicable 10, Phase 4 10, Phase 3 8, Phase 2 8, Phase 1/2 2, Phase 1 7) 2016: 77 trials (Observational 19, Not applicable 13, Phase 4 11, Phase 3 12, Phase 2/3 1, Phase 2 7, Phase 1/2 3, Phase 1 11) 2017: 78 trials (Observational 25, Not applicable 15, Phase 4 13, Phase 3 8, Phase 2 6, Phase 1 11) 2018: 85 trials (Observational 21, Not applicable 16, Phase 4 7, Phase 3 14, Phase 2/3 4, Phase 2 14, Phase 1/2 1, Phase 1 8) 2019: 91 trials (Observational 27, Not applicable 18, Phase 4 13, Phase 3 9, Phase 2/3 2, Phase 2 10, Phase 1/2 5, Phase 1 7) 2020: 59 trials (Observational 24, Not applicable 8, Phase 4 5, Phase 3 7, Phase 2/3 1, Phase 2 8, Phase 1/2 1, Phase 1 5) 2021: 90 trials (Observational 31, Not applicable 19, Phase 4 11, Phase 3 12, Phase 2 9, Phase 1/2 5, Phase 1 3) 2022: 74 trials (Other 1, Observational 20, Not applicable 14, Phase 4 8, Phase 3 4, Phase 2/3 1, Phase 2 10, Phase 1/2 5, Phase 1 11) 2023: 76 trials (Observational 25, Not applicable 17, Phase 4 11, Phase 3 6, Phase 2/3 1, Phase 2 6, Phase 1/2 3, Phase 1 7) 2024: 83 trials (Observational 24, Not applicable 22, Phase 4 4, Phase 3 8, Phase 2/3 2, Phase 2 16, Phase 1/2 5, Phase 1 2) 2025: 76 trials (Observational 25, Not applicable 16, Phase 4 14, Phase 3 5, Phase 2/3 2, Phase 2 6, Phase 1/2 1, Phase 1 7)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 80
2025 76
2024 83
2023 76
2022 74
2021 90
2020 59
2019 91
2018 85
2017 78

Forecast of the full-year count, planned starts included, not rows of this table: about 97 trials starting in 2026 and about 83 in 2027, the average of the 24 months through September, counted as registered and carried forward, with about 0.7 times the starts already registered for the rest of 2026 added. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 15 percent and ran about 1 percent high against the count later registered; forecasts made before the year began were off by about 26 percent and ran about 20 percent low against the count later registered. The part-way figures are from forecasts that used a multiple fitted only on earlier years. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 102 trials still running at the 2026-10-09 snapshot; registered median of 17 months across 1,298 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Gram-Negative Bacterial Infections trials in? (10)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 142
Phase 1/2 51
Phase 2 268
Phase 2/3 27
Phase 3 371
Phase 4 240
Not applicable 288
Observational 456
Expanded access 3
Unknown 1

How many Gram-Negative Bacterial Infections trials are recruiting? (11)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 63
Recruiting 150
Enrolling by invitation 6
Active, not recruiting 43
Completed 1,265

Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Gram-Negative Bacterial Infections trials? (7)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
GlaxoSmithKline 194
Sanofi Pasteur, a Sanofi Company 115
National Institute of Allergy and Infectious Diseases (NIAID) 65
Novartis Vaccines 61
Pfizer 28

Which drugs are being tested for Gram-Negative Bacterial Infections? (3)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
MENJUGATE 14
Benzathine Penicillin G 14
Meningitec 13

Interventions as named in the registry (12)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
1% Azithromycin 54
Doxycline 36
Ceftriaxone 4g/ 24h 32
InfanrixTM hexa 29
PO ciprofloxacin 20

These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Gram-Negative Bacterial Infections trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Preterm delivery 2,457 1
Small for gestational age 2,457 1
Congenital anomalies of eye 2,121 1
Congenital anomalies of upper gastrointestinal system 1,719 1
Preeclampsia/eclampsia 1,468 1

Which publications cover Gram-Negative Bacterial Infections? (346)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Nanomotion-based technology for rapid antibiotic susceptibility testing among adult patients admitted to a tertiary-care hospital with Gram-negative bacteraemia: a prospective, single arm, comparative diagnostic accuracy study. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases 2026 Yes
Pharmacokinetics, Safety and Tolerability of Single-dose or Multiple-dose Cefiderocol in Hospitalized Pediatric Patients Three Months to Less Than Eighteen Years Old With Infections Treated With Standard-of-care Antibiotics in the PEDI-CEFI Phase 2 Study. The Pediatric infectious disease journal 2025 Yes
Aztreonam-avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial. The Lancet. Infectious diseases 2025 Yes
Impact of reporting rapid susceptibility results in Gram negative bloodstream infections: a real world prospective study. European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology 2025 Yes
Cefiderocol treatment for patients infected by Stenotrophomonas maltophilia, Burkholderia cepacia complex and Achromobacter spp.: subgroup analysis from the PERSEUS study. European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology 2025 Yes

Sub-conditions in MeSH (24)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence and rare-disease identity.

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