trimethoprim-sulfamethoxazole
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BACTRIM | — | 1973-07-30 | fda.gov ↗ |
Trials 63 · started per year
Also used as a comparator or background therapy in 51 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05100654 Comparator | Apr 2022 → Dec 2027 expected | erectile dysfunction, prosthesis-related infectious disease | University of Chicago | Active not recruiting | No outcome recorded |
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT03178149 Background | Jul 2018 → Jun 2026 overdue | age-related macular degeneration | Astellas Institute for Regenerative Medicine | Recruiting | No outcome recorded |
| Phase 1 | NCT01042704 Background | Feb 2008 → Jan 2011 | plasma cell myeloma | Robert Redner, MD | Completed | No outcome recorded |
| Phase 1 | NCT00004216 Background | Aug 1999 → Jan 2008 | cancer of unknown primary site | Vion Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00061945 Background | Jun 2003 → Dec 2007 | B-cell adult acute lymphocytic leukemia, B-cell childhood acute lymphoblastic leukemia, T-cell adult acute lymphocytic leukemia, T-cell childhood acute lymphocytic leukemia +1 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT01756924 Comparator | Dec 2012 → Jul 2014 | periprosthetic joint infection | Arrevus Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01701297 Comparator | Feb 2012 → Oct 2014 | cirrhosis of liver | Nottingham University Hospitals NHS Trust | Terminated | No outcome recorded |
| Phase 2 | NCT01229761 Comparator | May 2011 → Mar 2015 | HIV infectious disease, anemia, neutropenia | Harvard School of Public Health (HSPH) | Completed | No outcome recorded |
| Phase 2 | NCT01114048 Background | Mar 2010 → Mar 2012 | plasma cell myeloma | Chonnam National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT00869518 Comparator | Jul 2009 → Dec 2010 | HIV infectious disease, staphylococcus aureus infection | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 2 | NCT00109837 Background | Apr 2005 → Nov 2010 | leukemia | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00391651 Comparator | Jan 2002 → Jul 2005 | urinary tract infection | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT00023244 Background | Jan 2001 → Jun 2005 | end stage renal failure | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT00002571 Background | Jun 1994 → Nov 2003 | lymphoma | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00002524 Background | Jun 1993 → Oct 2005 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT04851015 Comparator | Nov 2025 → Sep 2030 expected | pneumocystosis | Todd C. Lee MD MPH FIDSA | Recruiting | No outcome recorded |
| Phase 3 | NCT05074147 Background | May 2022 → Nov 2024 | osteomyelitis | Tourcoing Hospital | Withdrawn | No outcome recorded |
| Phase 3 | NCT05384197 Comparator | May 2022 → May 2023 | nephrolithiasis | Mansoura University | Unknown | No outcome recorded |
| Phase 3 | NCT04723940 Comparator | Jan 2021 → Jan 2023 | periprosthetic joint infection | Rothman Institute Orthopaedics | Unknown | No outcome recorded |
| Phase 3 | NCT04368559 Comparator | May 2020 → Jan 2026 | aspergillosis, candidemia, pneumocystosis | Mundipharma Research Limited | Completed | No outcome recorded |
| Phase 3 | NCT02773407 Comparator | May 2016 → Aug 2019 | unexplained long-lasting fever/inflammatory syndrome | Oxford University Clinical Research Unit, Vietnam | Completed | No outcome recorded |
| Phase 3 | NCT01449877 Comparator | Oct 2011 → Nov 2013 | ocular toxoplasmosis | University of Campinas, Brazil | Completed | No outcome recorded |
| Phase 3 | NCT00934492 Comparator | Nov 2009 → Apr 2014 | infectious disease, nutritional disorder | University of Oxford | Completed | No outcome recorded |
| Phase 3 | NCT00752375 Comparator | Feb 2009 → Dec 2014 | pyelonephritis | University of Alberta | Withdrawn | No outcome recorded |
| Phase 3 | NCT00973765 Comparator | Nov 2007 → Aug 2009 | abscess | 59th Medical Wing | Completed | No outcome recorded |
| Phase 3 | NCT00302341 Comparator | May 2006 → Dec 2008 | HIV infectious disease, pneumocystosis | Immtech Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT00791505 Comparator | Jul 2002 → Jun 2005 | chronic obstructive pulmonary disease, infectious disease with sepsis | University of Monastir | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT07236944 Comparator | Dec 2025 → Mar 2029 expected | bacterial urinary tract infection | Uppsala University | Recruiting | No outcome recorded |
| Phase 4 | NCT05977868 Background | Aug 2023 → Feb 2025 | digestive system infectious disorder | West Virginia University | Terminated | No outcome recorded |
| Phase 4 | NCT05274672 Comparator | Mar 2023 → Feb 2025 | benign prostatic hyperplasia, urinary tract infection | Baylor Research Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT05575427 Background | Nov 2022 → Jul 2024 | nosocomial infection | Mahidol University | Unknown | No outcome recorded |
| Phase 4 | NCT03633643 Comparator | Oct 2018 → Oct 2022 | prostatocystitis | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 4 | NCT03187834 Comparator | Jul → Sep 2017 | — | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT03087890 Comparator | Mar 2017 → Jul 2019 | HIV infectious disease, pneumocystosis | University of Bergen | Completed | No outcome recorded |
| Phase 4 | NCT02357758 Comparator | Sep 2012 → Jan 2016 | urinary tract infection | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase 4 | NCT01659866 Comparator | Aug 2012 → Aug 2015 | infectious disease | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT01420341 Comparator | Aug 2011 → Jun 2019 | melioidosis | Khon Kaen University | Completed | No outcome recorded |
| Phase 4 | NCT00674921 Comparator | Jun 2008 → Jun 2011 | HIV infectious disease | MRC/UVRI and LSHTM Uganda Research Unit | Unknown | No outcome recorded |
| Phase 4 | NCT00636935 Background | Feb 2008 → Aug 2013 | pneumocystosis | George Washington University | Withdrawn | No outcome recorded |
| Phase 4 | NCT02123628 Comparator | Jun 2007 → Jun 2010 | diabetes mellitus | Tourcoing Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02028676 Comparator | Mar 2007 → Mar 2012 | HIV infectious disease | Medical Research Council | Completed | No outcome recorded |
| Phase 4 | NCT00679302 Comparator | Jul 2006 → Feb 2008 | skin infection | St. Louis University | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT06207786 Background | Sep 2024 → May 2029 | epidermal appendage tumor, skin cancer | Mayo Clinic | Withdrawn | No outcome recorded |
| — | NCT06080698 Comparator | Feb 2024 → May 2027 expected | gram-negative bacterial infections | Johns Hopkins University | Recruiting | No outcome recorded |
| — | NCT01650558 Comparator | Nov 2012 → Jul 2018 | HIV infectious disease | University of Maryland, Baltimore | Completed | No outcome recorded |
| — | NCT00829686 Comparator | Jun 2008 | abscess | 59th Medical Wing | Completed | No outcome recorded |
| — | NCT01049438 Background | Aug 2006 → Sep 2009 | methicillin-resistant staphylococcus aureus infectious disease | Natividad Medical Center | Completed | No outcome recorded |
| — | NCT00189098 Comparator | Feb 2003 → Jun 2006 | chronic otitis media | UMC Utrecht | Completed | No outcome recorded |
| — | NCT00023231 Background | Feb 2001 → Aug 2004 | end stage renal failure | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00187070 Background | Dec 1997 → Jul 2001 | non-Hodgkin lymphoma | St. Jude Children's Research Hospital | Completed | No outcome recorded |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 126 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | trimethoprim-sulfamethoxazole | “338 women aged 18 to 45 years with acute uncomplicated cystitis were randomized to open-label treatment with either trimethoprim-sulfamethoxazole, 1 double-strength tablet...” PMID 17998493 ↗ Nov 200763“Isolates were frequently resistant to co-trimoxazole (trimethoprim/sulfamethoxazole) (71.1%) but less so to azithromycin (22.4%), erythromycin (21.1%), chloramphenicol (18.4%),...” PMID 32653726 ↗ Jul 2020 “The study medication Cotrimoxazole (Trimethoprim/Sulfamethoxazole) is a routinely used antimicrobial substance recommended in international and in-house guidelines for...” NCT03633643 ↗ “The aim of this study is to add trimethoprim-sulfamethoxazole (TMP-SMX) to standard of care treatment of AECOPD in patients who are colonized with PJ will improve the clinical...” NCT05418777 ↗ “A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients” NCT00000655 ↗ “rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days” NCT00869518 ↗ “We evaluate whether trimethoprim-sulfamethoxazole reduces the rate of treatment failures during the 7 days after incision and drainage” PMID 20346539 ↗ Mar 2010 “* Trimethoprim-sulfamethoxazole (800mg/160mg) : once per day if patient \< 80Kg ; one and a half per day if patient \> 80Kg.” NCT05074147 ↗ “one dose of either Trimethoprim (if \< 2 months) or Trimethoprim-Sulfamethoxazole (if ≥ 2 months) or placebo in suspension.” NCT05438082 ↗ “Cotrimoxazole (trimethoprim-sulfamethoxazole) is a relatively 'old' drug commonly used for urinary tract infections.” NCT00427076 ↗ “We then assessed the response of uropathogenic E. faecalis to nitrofurantoin and trimethoprim-sulfamethoxazole.” PMID 30132694 ↗ Aug 2018 “daily trimethoprim-sulfamethoxazole (TS) prophylaxis reduced morbidity and mortality among HIV-infected adults” PMID 27431995 ↗ Jul 2016 “Includes antibiotics such as amoxicillin, cephalexin, ciprofloxacin, and trimethoprim-sulfamethoxazole.” NCT06080698 ↗ “trimethoprim-sulfamethoxazole 160/800mg po bid or doxycycline 100mg po bid all for 7 days” NCT01232231 ↗ “followed by oral trimethoprim-sulfamethoxazole (TMP-SMX) for 12 to 20 weeks.” PMID 32725199 ↗ Dec 2021 “trimethoprim-sulfamethoxazole (TMP-SMX) works to treat invasive infections” NCT06982105 ↗ “metronidazole, moxifloxacin, rifampin, trimethoprim-sulfamethoxazole” NCT05977868 ↗ “* Trimethoprim- sulfamethoxazole IV and PO 800/160mg thrice daily” NCT02123628 ↗ “ciprofloxacin, 2) trimethoprim-sulfamethoxazole, 3) amoxicillin” NCT07236944 ↗ “bactrim, trimethoprim sulfamethoxazole, Septra, sulfatrim” NCT04230746 ↗ “Cotrimoxazole (trimethoprim sulfamethoxazole)” NCT00137657 ↗ “Trimethoprim/Sulfamethoxazole (TMP/SMX)” NCT00729937 ↗ “Trimethoprim / Sulfamethoxazole” NCT05823467 ↗ “T rimethoprim-Sulfamethoxazole” NCT02099240 ↗ “Trimethoprim-sulfamethoxazole” NCT06207786 ↗ “trimethoprim-sulfamethoxazole” NCT01049438 ↗ |
| Known as | Bactrim | “antibiotics (Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone)” NCT00636935 ↗10“PCP antibiotic prophylaxis with a Bactrim will be recommended.” NCT01042704 ↗ “Bactrim prophylaxis during dexamethasone administration” NCT01114048 ↗ |
| Known as | Bactrim DS | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07561541 ↗ |
| Known as | Bactrim F | “Other names: cotrimoxazole, sulfamethoxazole-trimethoprim. Bactrim F” NCT07224997 ↗ |
| Known as | Bactrim Inf Konz | “Single-dose Trimethoprim (TMP)/sulfamethoxazole (SMX, i.e. Cotrimoxazole) perioperative as two ampoules of TMP/SMX 400/80 mg (Bactrim Inf Konz®) solved in 250 ml sodium...” NCT03633643 ↗ |
| Known as | co-trimoxazole | “We randomly assigned eligible participants (1:1) to 6 months of either daily oral co-trimoxazole prophylaxis (given as water-dispersible tablets; 120 mg per day for age <6...” PMID 27265353 ↗ Jun 201644“Isolates were frequently resistant to co-trimoxazole (trimethoprim/sulfamethoxazole) (71.1%) but less so to azithromycin (22.4%), erythromycin (21.1%), chloramphenicol (18.4%),...” PMID 32653726 ↗ Jul 2020 “The study medication Cotrimoxazole (Trimethoprim/Sulfamethoxazole) is a routinely used antimicrobial substance recommended in international and in-house guidelines for...” NCT03633643 ↗ “Cotrimoxazole is a common antibiotic used to treat a variety of illnesses, including urinary and respiratory tract infections and opportunistic pneumocystis pneumonia, and...” NCT04884490 ↗ “HEU children in Botswana were randomly assigned to receive co-trimoxazole (100 mg/20 mg once daily until age 6 months and 200 mg/40 mg once daily thereafter) or placebo from...” PMID 28395844 ↗ May 2017 “Cotrimoxazole (sulfamethoxazole/trimethoprime) 30mg/kg/day (2 divided doses) OR Cefixime 8mg/kg/day (2 divided doses) during 7 days” NCT05544565 ↗ “comparing no prophylaxis with prophylaxis (co-trimoxazole 15 mg/kg per day or co-amoxiclav 15 mg/kg per day) for 12 months.” PMID 18977988 ↗ Nov 2008 “subjects received cotrimoxazole (1 tablet of 800 mg sulfamethoxazole/160 mg trimethoprim daily) alone for 2 weeks” PMID 15470330 ↗ Oct 2004 “Co-trimoxazole is a sulfamide preparation used to prevent opportunistic infections in HIV-infected patients” PMID 23945130 ↗ Aug 2013 “INTERVENTIONS: Sulfamethoxazole-trimethoprim (co-trimoxazole) or placebo for seven days.” PMID 17060336 ↗ Oct 2006 “Isoniazid or placebo given with co-trimoxazole either daily or three times a week.” PMID 17085459 ↗ Nov 2006 “Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg.” NCT05678621 ↗ “Other names: cotrimoxazole, sulfamethoxazole-trimethoprim. Bactrim F” NCT07224997 ↗ “Co-Trimoxazole 960Mg Dispersible Tablet” NCT04395365 ↗ “daily Co-trimoxazole (CTX) prophylaxis” PMID 24830749 ↗ May 2014 |
| Known as | Cotrimoxazole (septrin) | “Cotrimoxazole (septrin)” NCT01701297 ↗ |
| Known as | Cotrimoxazole Forte | “The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.” NCT04985110 ↗ |
| Known as | CTX | “Long Term Study of 2 Isoniazid (INH) Prophylactic Regimens With Concomitant Cotrimoxazole (CTX) in HIV-infected Children - Impact on Morbidity, Mortality, Bacterial Resistance...” NCT00330304 ↗2“prophylactic cotrimoxazole (CTX) remains widely used to reduce morbidity and mortality in the event of HIV infection among exposed infants” PMID 29119726 ↗ Nov 2017 “CTX” NCT00711906 ↗ |
| Known as | Septra | “A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients” NCT00000655 ↗ |
| Known as | SMX/TMP | “To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine...” NCT00000816 ↗3“Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis...” NCT00000991 ↗ “In Part A, patients receive sulfamethoxazole-trimethoprim (SMX/TMP) alone for 2 weeks, then in combination with fluconazole, rifabutin, or both drugs, each over 2-week periods...” NCT00000826 ↗ “sulfamethoxazole/trimethoprim (SMX/TMP)” NCT00000730 ↗ |
| Known as | Sulfamethoxazole 800mg + Trimethoprim 160mg = Bactrim F. | “Sulfamethoxazole 800mg + Trimethoprim 160mg = Bactrim F.” NCT01449877 ↗ |
| Known as | Sulfamethoxazole Trimethoprim Combination | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05274672 ↗ |
| Known as | sulfamethoxazole/trimethoprim | “The objective of this study was to evaluate the PK parameters and in vitro PD data on the effective part of co-trimoxazole: sulfamethoxazole. In a prospective PK study in...” PMID 27067336 ↗ Jun 201614“To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine...” NCT00000816 ↗ “Both sulfamethoxazole/trimethoprim (SMX/TMP) and dapsone probably also provide effective preventive treatment against PCP, and both may be useful in preventing toxoplasmosis...” NCT00000991 ↗ “A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients” NCT00000655 ↗ “Sulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 2 days” NCT05384197 ↗ “Other names: cotrimoxazole, sulfamethoxazole-trimethoprim. Bactrim F” NCT07224997 ↗ “sulfamethoxazole/trimethoprim (SMX/TMP)” NCT00000730 ↗ |
| Known as | sulfamethoxazole/trimethoprime | “Cotrimoxazole (sulfamethoxazole/trimethoprime) 30mg/kg/day (2 divided doses) OR Cefixime 8mg/kg/day (2 divided doses) during 7 days” NCT05544565 ↗ |
| Known as | SXT | “The objective of this study was to evaluate the PK parameters and in vitro PD data on the effective part of co-trimoxazole: sulfamethoxazole. In a prospective PK study in...” PMID 27067336 ↗ Jun 2016 |
| Known as | TMP-SMX | “Single-dose Trimethoprim (TMP)/sulfamethoxazole (SMX, i.e. Cotrimoxazole) perioperative as two ampoules of TMP/SMX 400/80 mg (Bactrim Inf Konz®) solved in 250 ml sodium...” NCT03633643 ↗18“The aim of this study is to add trimethoprim-sulfamethoxazole (TMP-SMX) to standard of care treatment of AECOPD in patients who are colonized with PJ will improve the clinical...” NCT05418777 ↗ “Low piperaquine concentrations were associated with an increased risk of recurrent malaria for up to 42 days, primarily in those receiving trimethoprim-sulfamethoxazole...” PMID 23447696 ↗ Feb 2013 “The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of TMP, is associated with serious adverse events” NCT04851015 ↗ “Trimethoprim-sulfamethoxazole (TMP-SMX) will be administered orally at a dose of 160 mg TMP and 800 mg SMX” NCT00730028 ↗ “Sulfamethoxazole-Trimethoprim (TMP-SMX) twice daily will be utilized as the first choice AP for 2 days” NCT05384197 ↗ “seven days of rifabutin plus trimethoprim-sulfamethoxazole (TMP-SMX) or TMP-SMX alone” NCT00869518 ↗ “followed by oral trimethoprim-sulfamethoxazole (TMP-SMX) for 12 to 20 weeks.” PMID 32725199 ↗ Dec 2021 “trimethoprim-sulfamethoxazole (TMP-SMX) works to treat invasive infections” NCT06982105 ↗ “Trimethoprim-Sulfamethoxazole (TMP/SMX) 160/800 mg tablets every 48 hours” NCT07224997 ↗ “common antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX)” NCT07106125 ↗ “Oral Co-trimoxazole (TMP-SMX) 160/800mg twice daily.” NCT04310930 ↗ “Drug: trimethoprim-sulfamethoxazole (TMP-SMX)” NCT00711854 ↗ “Trimethoprim-sulfamethoxazole (TMP/SMX)” NCT07451171 ↗ “Trimethoprim-Sulfamethoxazole (TMP-SMX)” NCT00302341 ↗ “Trimethoprim/Sulfamethoxazole (TMP/SMX)” NCT00729937 ↗ “TMP-SMX DS po BID for 14 days” NCT00469274 ↗ |
| Known as | TMP-SMZ | “Co-Trimoxazole; TMP-SMZ” NCT00198627 ↗ |
| Action | Inhibit | “blocks two steps of folate metabolism” NCT00934492 ↗ |
| Modality | Small molecule | “co-trimoxazole is a sulfamide preparation used to prevent opportunistic infections” PMID 23945130 ↗ Aug 2013 |
| Route | Oral | “1 double throughout strength treatment tablet po on Monday, Wednesday, and Friday x 6, 21 day cycles” NCT00002571 ↗ |