Miltefosine
Treatment for Visceral Leishmaniasis
Typical Dosage: Adults: 50 mg twice daily; Children: 2.5 mg/kg daily
Effectiveness
92%
Safety Score
60%
Clinical Trials
12
Participants
3.5K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
60
DangerousModerateSafe
Treatment Details
Dosage Range
Adults: 50 mg twice daily; Children: 2.5 mg/kg daily
Time to Effect
1-2 weeks
Treatment Duration
28 days
Evidence Quality
HIGHNumber Needed to Treat (NNT)
1(Treat 1 patients to see 1 additional successful outcome)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$1,500
Monitoring:$2,000
Side Effect Mgmt:$500
Total Annual:$4,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
GOODQALYs Gained
1
Outcome-Based Costs
Cost per Responder
$4,348
Cost per Remission
$4,348
Comparison vs Liposomal Amphotericin B
Cost Difference
$-14,000/year
Less expensive
QALY Difference
-0.20 QALYs
Worse outcomes
Dominance
No dominance
Active Clinical Trials
No active trials currently recruiting for this treatment
No active trials found in ClinicalTrials.gov
Completed Clinical Trials
11 completed trials for Miltefosine in Visceral Leishmaniasis
Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa
NCT02431143COMPLETEDPHASE2
30 participants
INTERVENTIONAL
Kacheliba, Kenya +1 more
Started: May 1, 2015
Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa
NCT03129646COMPLETEDPHASE3
439 participants
INTERVENTIONAL
Ābderafī, Ethiopia +6 more
Started: Jan 24, 2018
Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients.
NCT02011958COMPLETEDPHASE3
59 participants
INTERVENTIONAL
Abdurafi, Ethiopia +1 more
Started: Jul 1, 2014
Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar
NCT00371995COMPLETEDPHASE2
150 participants
INTERVENTIONAL
Muzaffarpur, India +1 more
Started: Oct 1, 2007
Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh
NCT01122771COMPLETEDPHASE3
602 participants
INTERVENTIONAL
Bhaluka, Bangladesh +3 more
Started: May 1, 2010
Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis
NCT00696969COMPLETEDPHASE3
634 participants
INTERVENTIONAL
Muzaffarpur, India +1 more
Started: Jun 1, 2008
Miltefosine for Children With PKDL
NCT02193022COMPLETEDPHASE3
80 participants
INTERVENTIONAL
Dhaka, Bangladesh
Started: Jul 1, 2014
Combination Therapy in Indian Visceral Leishmaniasis
NCT00523965COMPLETEDPHASE3
624 participants
INTERVENTIONAL
Muzaffarpur, India
Started: Sep 1, 2007
Combination Chemotherapy for the Treatment of Indian Kala-Azar
NCT00370825COMPLETEDPHASE2
200 participants
INTERVENTIONAL
Muzaffarpur, India
Started: Sep 1, 2006
Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa
NCT01067443COMPLETEDPHASE2
151 participants
INTERVENTIONAL
Kimalel, Kenya +2 more
Started: Mar 1, 2010
A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL)
NCT01975051COMPLETEDPHASE4
36 participants
INTERVENTIONAL
Dhaka, Bangladesh
Started: Jan 1, 2013