A Phase 2 interventional study of Amphotericin B and Fluconazole in Cryptococcal Meningitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 15 sites in 2 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2012-05-16.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
This study will examine the effectiveness and safety of a combination treatment for cryptococcal meningitis, a fungal infection common in persons with acquired immune deficiency syndrome (AIDS) in the developing world. The standard initial treatment includes two medications: amphotericin B for 2 weeks followed by 8 weeks of fluconazole. This study will look at whether study participants recover more quickly and have fewer side effects if they are given both drugs at the same time for 2 weeks followed by 8 weeks of fluconazole as compared to the standard treatment. Participants will be followed for approximately 6 months from the time they are enrolled into the study.
This study is designed to address the need for more effective antifungal therapy for cryptococcal meningitis. This is a prospective, randomized, open-label, multicenter phase II clinical trial of combination therapy for the treatment of acute cryptococcal meningitis in HIV-positive subjects. The primary study objectives will be to assess the safety and tolerability of the study drug regimens; and to determine whether the safety and efficacy of combination therapy supports development of a phase III trial of combination therapy, and if so, to select the most appropriate dose of fluconazole plus amphotericin B based on safety and efficacy to be evaluated in a subsequent phase III trial. Secondary study objectives include: comparing the efficacy of the study drug treatments at 2, 6, and 10 weeks (Days 14, 42, and 70); comparing the findings on detailed neurological examination between study arms at baseline and 2, 6, 10, and 24 weeks (6 months); assessing the proportion of subjects in each study arm that are alive at 6 months after initiation of study therapy; describing the effects of baseline clinical, neurological, and mycological characteristics on mycological failure at 2 and 10 weeks; measuring time to cerebrospinal fluid (CSF) culture negatively for each study arm; assessing the length of hospitalization in the treatment groups as a surrogate of cost efficacy; assessing the incidence of immune reconstitution inflammatory syndrome among all subjects receiving highly active antiretroviral therapy (HAART); and examining antifungal susceptibility of all cryptococcal isolates. Study participants will include 150 subjects ages 13 and older. Subjects will be randomly assigned to 1 of 3 treatment arms including 1 standard therapy and 2 investigational arms. The standard treatment arm will include amphotericin B 0.7 mg/kg (IV) for 14 days followed by 8 weeks (56 days) of fluconazole at 400 mg/day orally. The 2 investigational arms will include daily amphotericin B 0.7 mg/kg (IV) and the randomized dose of fluconazole 400 mg/day or 800 mg/day for the first 14 day, then the randomized dose of fluconazole at 400 mg/day or 800 mg/day respectively for an additional 8 weeks (56 days). At the completion of study therapy, all subjects will receive chronic suppressive therapy with oral fluconazole at a dose of at least 200 mg/day. The safety endpoints are considered to be the primary endpoints for this study. The safety assessment for each treatment arm will end at study day 100 for each subject. The key safety endpoint will be the incidence of adverse experiences of grade 3-5 (total and attributed to the treatment regimens). The primary safety endpoint will examine the incidence of grade 3-5 adverse experiences that are definitely or probably related to study drugs, while secondary analysis will include grade 3-5 adverse experiences that are, definitely probably or possibly related to study drugs. Another secondary safety endpoint will be the number of dose-limiting toxicities attributed to the treatment regimens. Key efficacy endpoint (treatment success) will be a composite of the following 3 mycologic and clinical measures after 14, 42, and 70 days of therapy: CSF culture conversion; neurologically stable or improved; and alive. Other secondary efficacy endpoints that will be evaluated descriptively are: CSF culture conversion at multiple time points; all-cause mortality; length of hospitalization; and incidence of immune reconstitution inflammatory syndrome.
54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.
This study's enrollment of 143 is close to the median of 143 across 35 interventional studies indexed under Meningitis, Cryptococcal.
Browse Meningitis, Cryptococcal studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
-Presumptive diagnosis of HIV-1 by approved rapid testing method at screening. This testing must be confirmed by a second ELISA (or Western blot), a positive HIV antigen, or HIV RNA detection within 10 days of study entry.
OR
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
Drug: Amphotericin B · Drug: Fluconazole
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
Drug: Amphotericin B · Drug: Fluconazole
Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
Drug: Amphotericin B · Drug: Fluconazole
Amphotericin B 0.7 mg/kg IV for the first 14 days of treatment. This period may be extended up to an additional 7 days.
Fluconazole 400 or 800 mg daily. Among subjects whose baseline weight is less than 40 kg, randomized fluconazole doses will be 200 mg/kg daily or 400 mg/kg daily.
Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug
Events are reported by MedDRA Preferred Term. Grade 3 - Severe. Incapacitating; inability to perform usual activities and daily tasks; significantly affects clinical status; requires therapeutic intervention. Grade 4 - Life-threatening. AE is life-threatening. Grade 5 - Death. AE causes death.
Time frame: Day 100
Number of Dose-limiting Toxicities Attributed to Treatment Regimens
Events are reported by MedDRA Preferred Term. Dose limiting toxicities include events that resulted in study drug being adjusted, interrupted, or discontinued.
Time frame: Day 100
Number of Deaths
Number of deaths occurring on study. Day = Day relative to the first dose of study drug.
Time frame: 14, 42, and 70 days
Number of Subjects With Cerebrospinal Fluid (CSF) Culture Conversion at Multiple Time Points
Number of subjects that have a negative fungal culture at Baseline, Day 14, Day 42, and Day 70.
Time frame: Baseline, 14, 42, and 70 days
Number of Subjects Meeting the Key Efficacy Endpoint of Treatment Success
Treatment success is defined as a composite of the 3 mycologic and clinical measures: CSF culture conversion; neurologically stable or improved; and alive
Time frame: 14, 42, and 70 days
Number of Subjects Reporting Immune Reconstitution Inflammatory Syndrome (IRIS)
Number of subjects reporting immune reconstitution inflammatory syndrome (IRIS) following treatment. Day = Day relative to first dose of study drug
Time frame: 14, 42, and 70 days
Mean Days of Hospitalization
Mean days of hospitalization. Includes days subject was hospitalized prior to study enrollment for current hospital stay.
Time frame: 7, 14, 42, and 70 days
Number of Cryptococcal Isolates With Antifungal Susceptibility
Isolates were collected at days 14 and 70 for assessment of antifungal susceptibility.
Time frame: Days 14 and 70
Mean Change in Neurological Exam Score From Baseline - Day 14
Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.
Time frame: Baseline and Day 14
Mean Change in Neurological Exam Score From Baseline - Day 42
Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.
Time frame: Baseline and Day 42
Mean Change in Neurological Exam Score From Baseline - Day 70
Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.
Time frame: Baseline and Day 70
Mean Change in Neurological Exam Score From Baseline - Day 168
Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.
Time frame: Baseline and Day 168
Subjects were screened and enrolled at 10 sites in the US and 5 sites in Thailand.
| Milestone | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Started | 47 | 48 | 48 |
| Completed | 36 | 33 | 31 |
| Not completed | 11 | 15 | 17 |
Events are reported by MedDRA Preferred Term. Grade 3 - Severe. Incapacitating; inability to perform usual activities and daily tasks; significantly affects clinical status; requires therapeutic intervention. Grade 4 - Life-threatening. AE is life-threatening. Grade 5 - Death. AE causes death.
| Events | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Hypomagnesaemia | 2 | 1 | 0 |
| Hypokalaemia | 0 | 0 | 1 |
| Anaemia | 1 | 1 | 0 |
| Drug intolerance | 1 | 0 | 0 |
| Creatinine renal clearance increased | 0 | 0 | 1 |
| Psychotic disorder | 0 | 0 | 1 |
Events are reported by MedDRA Preferred Term. Dose limiting toxicities include events that resulted in study drug being adjusted, interrupted, or discontinued.
| Events | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| All Events | 6 | 7 | 14 |
| Blood creatinine increased | 4 | 1 | 1 |
| Creatinine renal clearance decreased | 0 | 1 | 2 |
| Creatinine renal clearance increased | 0 | 0 | 2 |
| Renal failure | 0 | 2 | 0 |
| Renal failure acute | 0 | 1 | 1 |
| Azotaemia | 0 | 0 | 1 |
| Renal impairment | 0 | 0 | 1 |
| Nausea | 0 | 0 | 1 |
| Vomiting | 0 | 0 | 1 |
| Drug intolerance | 1 | 1 | 0 |
| Chills | 0 | 1 | 0 |
| Neutropenia | 0 | 0 | 1 |
| Hepatitis acute | 1 | 0 | 0 |
| Pneumonia | 0 | 0 | 1 |
| Dehydration | 0 | 0 | 1 |
| Respiratory failure | 0 | 0 | 1 |
Number of deaths occurring on study. Day = Day relative to the first dose of study drug.
| Subjects | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| All Deaths | 10 | 8 | 9 |
| Day 1-14 | 3 | 2 | 1 |
| Day 15-42 | 3 | 2 | 1 |
| Day 43-70 | 1 | 2 | 5 |
| Day >70 | 3 | 2 | 2 |
Number of subjects that have a negative fungal culture at Baseline, Day 14, Day 42, and Day 70.
| Subjects | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Baseline - Negative | 0 | 0 | 0 |
| Day 14 - Negative | 20 | 13 | 22 |
| Day 42 - Negative | 35 | 37 | 36 |
| Day 70 - Negative | 36 | 39 | 38 |
Treatment success is defined as a composite of the 3 mycologic and clinical measures: CSF culture conversion; neurologically stable or improved; and alive
| Subjects | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Day 14 - Success | 19 | 13 | 22 |
| Day 42 - Success | 33 | 35 | 33 |
| Day 70 - Success | 33 | 36 | 32 |
Number of subjects reporting immune reconstitution inflammatory syndrome (IRIS) following treatment. Day = Day relative to first dose of study drug
| Subjects | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Day 1 through 70 | 2 | 0 | 1 |
| Day 1-14 | 0 | 0 | 0 |
| Day 15-42 | 1 | 0 | 0 |
| Day 43-70 | 1 | 0 | 1 |
Mean days of hospitalization. Includes days subject was hospitalized prior to study enrollment for current hospital stay.
| Days | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Day 7 | 8.9 ± 1.61 | 8.8 ± 2.39 | 8.1 ± 2.53 |
| Day 14 | 15.4 ± 1.78 | 15.1 ± 3.27 | 13.6 ± 4.37 |
| Day 42 | 16.3 ± 4.22 | 17.4 ± 5.91 | 16.5 ± 7.03 |
| Day 70 | 16.7 ± 4.54 | 20.1 ± 11.63 | 16.6 ± 8.24 |
Isolates were collected at days 14 and 70 for assessment of antifungal susceptibility.
No measurements were reported for this outcome.
Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.
| Scores on a scale | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Mean Change in Neurological Exam Score From Baseline - Day 14 | 0.5 ± 4.07 | 2.1 ± 3.74 | 3.5 ± 6.25 |
Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.
| Scores on a scale | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Mean Change in Neurological Exam Score From Baseline - Day 42 | 1.6 ± 2.58 | 1.8 ± 4.42 | 3.3 ± 7.9 |
Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.
| Scores on a scale | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Mean Change in Neurological Exam Score From Baseline - Day 70 | 1.5 ± 3.28 | 2.2 ± 3.58 | 4.2 ± 6.84 |
Neurological assessment by Mini-mental Status Exam (MMSE). This is collected as a continuous variable with values from 0-30; where lower scores indicate greater impairment.
| Scores on a scale | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| Mean Change in Neurological Exam Score From Baseline - Day 168 | 2.0 ± 2.28 | 2.8 ± 3.92 | 4.4 ± 7.58 |
Collected over Reported Adverse Events (AEs) include events starting on or after Day 0 and on or before Day 100.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AmphoB Standard | — | 22/45 (48.9%) | 44/45 (97.8%) |
| AmphoB+Fluc400 | — | 17/47 (36.2%) | 47/47 (100%) |
| AmphoB + Fluc800 | — | 26/49 (53.1%) | 49/49 (100%) |
| Event | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| SepsisInfections and infestations | 4/45 | 3/47 | 0/49 |
| Intracranial pressure increasedNervous system disorders | 3/45 | 2/47 | 2/49 |
| ConvulsionNervous system disorders | 2/45 | 3/47 | 0/49 |
| DehydrationMetabolism and nutrition disorders | 0/45 | 0/47 | 3/49 |
| Meningitis cryptococcalInfections and infestations | 2/45 | 1/47 | 1/49 |
| AnaemiaBlood and lymphatic system disorders | 2/45 | 0/47 | 0/49 |
| Immune reconstitution syndromeImmune system disorders | 2/45 | 0/47 | 1/49 |
| Pneumocystis jiroveci pneumoniaInfections and infestations | 1/45 | 2/47 | 1/49 |
| SinusitisInfections and infestations | 0/45 | 0/47 | 2/49 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/45 | 1/47 | 2/49 |
| Event | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 |
|---|---|---|---|
| HypokalaemiaMetabolism and nutrition disorders | 38/45 | 38/47 | 39/49 |
| HypomagnesaemiaMetabolism and nutrition disorders | 27/45 | 33/47 | 31/49 |
| AnaemiaBlood and lymphatic system disorders | 21/45 | 27/47 | 24/49 |
| VomitingGastrointestinal disorders | 14/45 | 14/47 | 16/49 |
| NauseaGastrointestinal disorders | 4/45 | 14/47 | 16/49 |
| HeadacheNervous system disorders | 10/45 | 13/47 | 14/49 |
| AnorexiaMetabolism and nutrition disorders | 12/45 | 8/47 | 7/49 |
| InsomniaPsychiatric disorders | 11/45 | 7/47 | 11/49 |
| ConstipationGastrointestinal disorders | 6/45 | 4/47 | 9/49 |
| PhlebitisVascular disorders | 4/45 | 5/47 | 8/49 |
| Age, Categorical(Participants) | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 1 | 1 |
| Between 18 and 65 years | 45 | 47 | 47 | 139 |
| >=65 years | 0 | 0 | 1 | 1 |
| Age Continuous(years) | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 | Total |
|---|---|---|---|---|
| Mean | 37.1 ± 8.47 | 36.5 ± 8.21 | 35.9 ± 9.44 | 36.5 ± 8.69 |
| Sex: Female, Male(Participants) | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 | Total |
|---|---|---|---|---|
| Female | 16 | 15 | 18 | 49 |
| Male | 29 | 32 | 31 | 92 |
| Region of Enrollment(participants) | AmphoB Standard | AmphoB+Fluc400 | AmphoB + Fluc800 | Total |
|---|---|---|---|---|
| United States | 14 | 14 | 14 | 42 |
| Thailand | 31 | 33 | 35 | 99 |
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Studies of the drugs tested here: Amphotericin B · Fluconazole
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