Evaluating the effect of oral clarithromycin on acute cutaneous leishmaniasis lesions compared with systemic glucantime

Zabolinejad, Nona; Layegh, Pouran; Shaye, Zahra Abbasi; Salehi, Maryam; Ghanizadeh, Somayeh

doi:10.1080/09546634.2020.1825612

Cited by 5 publications

(6 citation statements)

References 19 publications

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“…In view of the promising results from other studies, a pilot randomized clinical trial was conducted by Zabolinejad and collaborators, 40 where the intervention group received clarithromycin 500 mg tablets twice a day, while the control group received MGA (20 mg/kg/day), both for 2 months. There were no significant differences between groups throughout the study, only in the first month, in which clarithromycin demonstrated better results than the control group.…”

Section: Resultsmentioning

confidence: 99%

Cutaneous leishmaniasis: new oral therapeutic approaches under development

et al. 2021

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The World Health Organization (WHO) classifies leishmaniasis as a disease for which the development of new treatments is a priority. Available drugs are not fully effective in all cases; they have parenteral administration and exhibit serious and common adverse effects. The only oral drug available (miltefosine) has shown resistance, is expensive, and is not available in many endemic countries. Thus, the development of an oral medicine may solve many of these issues. Based on that, this review aimed to investigate which therapeutic alternatives have been studied for the development of oral drugs for the treatment of cutaneous leishmaniasis. A literature search for keywords “leishmania and oral” was performed in PubMed and ScienceDirect, considering articles published in the last 5 years. The articles were selected based on the objective of the review. The main problem in the current treatment of leishmaniasis is the administration of injectables, since it requires patients to travel to health centers, hospitalization, and professional administration, conditions that are not adapted to the socioeconomic reality of patients. Therefore, many research studies have evaluated oral alternatives for the treatment of cutaneous leishmaniasis. The main tested approaches were obtaining new molecules, repositioning drugs, and new formulations of old drugs. The prospects are encouraging but still require more in vivo bioavailability and clinical trials.

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Section: Resultsmentioning

confidence: 99%

Cutaneous leishmaniasis: new oral therapeutic approaches under development

et al. 2021

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“…Azithromycin has been used in a few research studies for CL with promising results. Possibly, due to its immunomodulatory activity, it can accelerate clinical improvement (Krolewiecki et al, 2002;Sinagra et al, 2007;Amer et al, 2016;Zabolinejad et al, 2020;Abtahi-Naeini et al, 2021). Given the similarity of clarithromycin and azithromycin, a possible therapeutic role in CL for clarithromycin has been proposed (Zabolinejad et al, 2020).…”

Section: Discussionmentioning

confidence: 99%

“…Possibly, due to its immunomodulatory activity, it can accelerate clinical improvement (Krolewiecki et al, 2002;Sinagra et al, 2007;Amer et al, 2016;Zabolinejad et al, 2020;Abtahi-Naeini et al, 2021). Given the similarity of clarithromycin and azithromycin, a possible therapeutic role in CL for clarithromycin has been proposed (Zabolinejad et al, 2020). Sazgarnia et al (2012) conducted an in vitro study and reported that clarithromycin administration in both liposomal and non-liposomal forms had significant activity against leishmaniasis and suggested that this therapeutic technique should be used in human subjects.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, Zabolinejad et al (2020) evaluated the effects of oral clarithromycin in combination with systemic Glucantime on 20 patients and reported that this technique significantly reduced lesion size and was considered a safe and effective treatment option. Our results also showed significant effects of liposomal clarithromycin on CL, which is consistent with the previous studies that have reported the efficacy of clarithromycin on CL.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study

Hakamifard,

Radmehr,

Sokhanvari

et al. 2023

Front. Pharmacol.

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Aim: This study aimed to investigate the effects of topical liposomal clarithromycin in combination with meglumine antimoniate (Glucantime®) on cutaneous leishmaniasis (CL) lesions.Methods: This pilot, randomized, double-blinded clinical trial was conducted on patients with CL lesions. Patients were randomly assigned to two groups: the first group received liposomal clarithromycin in combination with Glucantime for 28 days, while the second group received Glucantime and a placebo. Afterward, patients were followed up at 1.5, 3, and 6 months after treatment initiation and were evaluated for recovery time, induration, and size of the lesions.Results: Sixty patients with CL lesions were divided into two separate groups with 30 members each and were examined. Within-group analysis revealed that recovery time in the clarithromycin group was 26.65 ± 5.12 days, while in the placebo group, it was 32.84 ± 24.43, which was statistically insignificant (p = 0.18). Lesion size comparison in the first and last follow-ups reduced in both groups: 7.73 ± 4.31 to 0.48 ± 0.50 in the clarithromycin group (p = 0.006) and 5.47 ± 5.83 to 0.76 ± 0.88 in the placebo group (p = 0.03). Moreover, the size of lesions in the intervention group was significantly reduced compared to that in the placebo group (p = 0.02). Recognizable induration reduction was observed in the clarithromycin group (2.60 ± 0.77 to 1.0 ± 0.00). No adverse effects attributable to clarithromycin were reported.Conclusion: The administration of liposomal clarithromycin in combination with systemic Glucantime had a significant beneficial effect on reducing lesion size in leishmaniasis. Further studies on larger populations are recommended.Systematic Review Registration: https://www.irct.ir/trial/46611.

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“…Clarithromycin is a semi-synthetic macrolide with in vitro activity shown against Leishmania major [ 173 ]. In a pilot study in Iran, previously untreated patients were randomly assigned to clarithromycin ( N = 10, 500 mg twice a day for 2 months, mean ± standard deviation of lesion number 5 ± 4.3 and induration size 15.47 ± 15.6 mm) or three injections of glucantime ( N = 10, 20 mg/kg/day for 20 days; N = 10, lesion number 3 ± 2.8, induration size 19.81 ± 13 mm).…”

Section: Ntds Targeted For Controlmentioning

confidence: 99%

The pipeline for drugs for control and elimination of neglected tropical diseases: 2. Oral anti-infective drugs and drug combinations for off-label use

Pfarr,

Krome,

Al-Obaidi

et al. 2023

Parasites Vectors

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In its ‘Road map for neglected tropical diseases 2021–2030’, the World Health Organization outlined its targets for control and elimination of neglected tropical diseases (NTDs) and research needed to achieve them. For many NTDs, this includes research for new treatment options for case management and/or preventive chemotherapy. Our review of small-molecule anti-infective drugs recently approved by a stringent regulatory authority (SRA) or in at least Phase 2 clinical development for regulatory approval showed that this pipeline cannot deliver all new treatments needed. WHO guidelines and country policies show that drugs may be recommended for control and elimination for NTDs for which they are not SRA approved (i.e. for ‘off-label’ use) if efficacy and safety data for the relevant NTD are considered sufficient by WHO and country authorities. Here, we are providing an overview of clinical research in the past 10 years evaluating the anti-infective efficacy of oral small-molecule drugs for NTD(s) for which they are neither SRA approved, nor included in current WHO strategies nor, considering the research sponsors, likely to be registered with a SRA for that NTD, if found to be effective and safe. No such research has been done for yaws, guinea worm, Trypanosoma brucei gambiense human African trypanosomiasis (HAT), rabies, trachoma, visceral leishmaniasis, mycetoma, T. b. rhodesiense HAT, echinococcosis, taeniasis/cysticercosis or scabies. Oral drugs evaluated include sparfloxacin and acedapsone for leprosy; rifampicin, rifapentin and moxifloxacin for onchocerciasis; imatinib and levamisole for loiasis; itraconazole, fluconazole, ketoconazole, posaconazole, ravuconazole and disulfiram for Chagas disease, doxycycline and rifampicin for lymphatic filariasis; arterolane, piperaquine, artesunate, artemether, lumefantrine and mefloquine for schistosomiasis; ivermectin, tribendimidine, pyrantel, oxantel and nitazoxanide for soil-transmitted helminths including strongyloidiasis; chloroquine, ivermectin, balapiravir, ribavirin, celgosivir, UV-4B, ivermectin and doxycycline for dengue; streptomycin, amoxicillin, clavulanate for Buruli ulcer; fluconazole and isavuconazonium for mycoses; clarithromycin and dapsone for cutaneous leishmaniasis; and tribendimidine, albendazole, mebendazole and nitazoxanide for foodborne trematodiasis. Additional paths to identification of new treatment options are needed. One promising path is exploitation of the worldwide experience with ‘off-label’ treatment of diseases with insufficient treatment options as pursued by the ‘CURE ID’ initiative. Graphical abstract

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Evaluating the effect of oral clarithromycin on acute cutaneous leishmaniasis lesions compared with systemic glucantime

Cited by 5 publications

References 19 publications

Cutaneous leishmaniasis: new oral therapeutic approaches under development

Cutaneous leishmaniasis: new oral therapeutic approaches under development

Efficacy of adjunctive topical liposomal clarithromycin on systemic Glucantime in Old World cutaneous leishmaniasis: a pilot clinical study

The pipeline for drugs for control and elimination of neglected tropical diseases: 2. Oral anti-infective drugs and drug combinations for off-label use

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