Oropharyngeal Candidiasis
Conditions
Interventions
Experimental Group:Clotrimazole lozenge, 5 times/day for 14 days
Control Group:Clotrimazole lozenge, 5 times/day for 14 days
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged between 18 to 75 (inclusive); 2. Patients diagnosed to have oropharyngeal candidiasis; 3. Patients able to understand and comply with the study procedure, and able to communicate well with the investigator, voluntarily participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients judged by the investigator to have developed Candida infection beyond the oropharyngieal area (mainly deep fungal infectious disease), patients with newly developed fever or persistent fever with elevated white blood cell, and unresponsive to multiple antibiotics; 2. Patients diagnosed with hairy leukoplakia by the investigator; 3. Presence of only perioral lesions, e.g.,angular chelitis; 4. Exhibits signs or symptoms of candidal esophagitis or diagnosed with candidal esophagitis; 5. Recurrence of Oropharyngreal Candidiasis within 2 weeks prior to screening; 6. Patients with severe brain dysfunction (e.g. massive cerebral infarction, cerebral hemorrhage) or with history of psychosis; 7. History of intolerance (e.g., elevated liver enzymes) or sensitivity to clotrimazole (or other azole compounds) or any constituent of the investigational drugs, or unable to tolerant oral medication; 8. History of resistance to treatment with clotrimazole; 9. Has been taking oral or systemic antifungal medications (e.g., fluconazole, intraconazole, myclobutanil, amphotericin B, etc.) within 2 weeks prior to screening; 10. Has been treated with protease inhibitors for the first time within 1 month prior to screening (e.g., Ritonavir, indinavir, atazanavir, darunavir, tipranavir); 11. Has been taking medications known to have significant interaction with azoles (e.g. antacids (including aluminium hydroxide, magnesium trisilicate, calcium carbonate, magnesium aluminium carbonate), H2-receptor Blockers (including cimetidine, ranitidine), rifampin, phenytoic, carbamazepine, astemizole); 12. Patients with liver dysfunction (defined as AST or ALT value > 2 times the upper limit of normal, or total bilirubin . 1.5 times the upper limit or normal); 13. Neutrophil absolute value <500/mm3 (0.5*10^9/L); 14. Participants of other drug or medical device clinical trials or within 3 months prior to screening, except for non-interventional studies; 15. Pregnant or lactating female, or positive to pregnancy test prior to the clinical trial, male or his partner or female having a plan for pregnancy, sperm or egg donation from signing the informed consent to 3 months after last administration of investigational drug, or unwilling to use a medically approved contraceptive measure (e.g. IUD or condom); 16. Patients with other conditions to be unsuitable to participate in the study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total clinical resolution;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal inhibit concentration, MIC; | — |
Countries
China
Contacts
Public ContactXuemin Shen
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed