COMPARATIVE, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE SAFETY TOLERABILITY AND EFFICACY OF L-743,872 VS AMPHOTERICIN B IN THE TREATMENT OF CANDIDA ESOPHAGILITIS INFECTIONS IN ADULTS
- Conditions
- B37-B37 CandidiasisCandidiasis
- Registration Number
- PER-005-97
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
a) The patient must have been diagnosed with an esophageal candidiasis, documented according to the following criteria:
1. Symptoms such as odynophagia (pain when swallowing), dysphagia, feeling of food adherence in the retrostemal area or retrostemal pain.
2. Esophagoscopy with photographic documentation of the presence of characteristic mucosal plaques and evaluated prospectively as follows: Grade O = normal esophageal mucosa; Grade Vi = rare and scattered individual protruding plates, each with a size <2 mm; Grade I = scattered plaques with a size> 2 mm that cover less than 50% of the esophageal mucosa; Grade 2 = plates with a size> 2 mm that cover more than 50% of the esophageal mucosa; Grade 3 = confluent plates covering circumferentially more than half of the mucosa; Grade 4 = circumferential plates with narrowing of light despite insufflation.
3. Brushing esophageal plate with a wet preparation and staining with PAS to demonstrate the presence of Candida pseudohyphae (one culture was also performed).
4. biopsy esophageal lesions (to confirm the findings brushing) with histological evidence of pseudohyphae characteristics of Candida in conventional coloring, and confirmation by staining with silver methenamine, PAS or Giemsa; a crop will also be made.
b) Patients must be adults 18 to 65 years old (any sex). Women of childbearing age are eligible ONLY if they have HIV infection and if their doctor has carefully examined the risk / benefit relationship. Before admission to the study, HIV-positive women of childbearing age must undergo a pregnancy test (determination of serum b-HCG) to be negative result; subsequently they must use an adequate contraceptive method defined by the researcher. Oral contraceptives should not be used as the only contraceptive method since the effect of L-743,872 on the efficacy of these drugs has not yet been established. To be admitted to the study, women who are not HIV + must be sterile (surgical sterilization or more than one year after menopause).
c) Before the study, the ECG of the patients should be within normal limits. Benign alterations of the ECG will be allowed, according to the investigator´s criteria.
d) Before the study, the chest x-ray of the patients should not show signs of active lung disease.
e) The values of the following laboratory parameters must be obtained before admission to the study:
1. Hematocrit> 30% (men) and> 27% (women)
2. White blood cell count> 1000 / ul
3. Platelet count> 10,000 / ul
4. Creatinine within normal limits.
5. Prothrombin time and partial thromboplastin time within normal limits.
6. AST (TGO) and ALT (TGP) 7. Alkaline phosphatase <1 V2 times the upper limit of normal
a. The patient does not meet any of the inclusion criteria.
b. History of allergy, hypersensitivity or any adverse reaction to an antifungal of the echinocandin family or amphotericin B.
c. Women of childbearing or fertile age who do not suffer from HIV infection, regardless of their marital status. This group includes women who use oral, injectable or mechanical contraceptives, women whose sexual partners have been vasectomized, women who use mechanical barrier contraceptive devices and women who are susceptible to receiving fertilized ovules in vitro or to undergo insemination. artificial.
d. Patients in whom treatment with fluconazole or ketoconazole for an anterior esophageal candidiasis has failed.
e. Patients with an episode of esophageal candidiasis in the last 30 days.
f. Patients with AIDS whose life expectancy is less than 6 months.
g. Patients with AIDS and other opportunistic infections.
h. Patients with another cause of esophagitis (eg, CMV), in addition to Candida.
i. Patients with a history of infection with CMV and with the Mycobacterium avium complex (CMA).
j. Patients who can not undergo an esophagoscopy and an esophageal biopsy.
k. Patients in whom the esophagoscopy reveals the presence of ulcers.
l. Any patient with a diagnosis of cirrhosis or acute or chronic hepatitis of any etiology.
m. Participation in any other clinical study involving the administration of a research drug at the time of admission or during the conduct of the study. Previous participation in this study at any time.
n. Any concomitant disease that, according to the researcher, could produce confusion in the interpretation of the results of the study or expose the patient to an additional risk due to the administration of study drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Evaluation of the clinical response by the doctor made at the end of the 14-day treatment period.<br>Measure:Proportion of patients in each treatment group with a favorable clinical evaluation (absence of symptoms).<br>Timepoints:Day 14<br>;<br>Outcome name:Through endoscopy evaluation, which will be carried out before the treatment and 2 or 3 days after the suspension of the same.<br>The endoscopic response will be evaluated as healing (no injury persists), improvement (improvement of two grades, considering grade 1/2 as a degree between 0 and 1) and absence of improvement (improvement below two degrees).<br>Measure:Proportion of patients with an improvement of 2 degrees or more in the endoscopic response after 14 days of treatment, compared to the initial situation.<br>Timepoints:2 or 3 days after the suspension of the treatment.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The favorable evaluations of the final clinical response (symptoms) are: healing and improvement. An answer classified as a failure is considered unfavorable. Patients with a final clinical response assessed as indeterminate are not considered clinically evaluable.<br><br>The microbiological response will be evaluated after all the follow-up examinations have been carried out, using the definitions indicated below. Microbiological responses that are not indeterminate will be classified as favorable or unfavorable.<br>Measure:Total clinical / mycological cure rate in the treatment of mild to moderate esophageal candidiasis.<br>Timepoints:Day 14<br>