PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )
NCT ID: NCT03664063
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2018-09-01
2019-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Azithromycin for Yaws
Patients will receive standard treatment for yaws alone
Azithromycin
Treatment with Azithromycin single dose - weight based dosing max 2gm
IDA for Lymphatic Filariasis
Patients will receive standard IDA (Ivermectin \& Diethylcarbamazine \& Albendazole) treatment for Lymphatic Filariasis alone
Albendazole
Single dose of Albendazole weight based dosing
\- 400mg
Ivermectin
Ivermectin weight based dosing - max 21mg
Diethylcarbamazine
Diethylcarbamazine weight based dosing - max 500mg
Combination Therapy of Azithromycin for Yaws and IDA for LF
Patients will receive combination therapy for both yaws and IDA for Lymphatic Filariasis at the same time.
Azithromycin
Treatment with Azithromycin single dose - weight based dosing max 2gm
Albendazole
Single dose of Albendazole weight based dosing
\- 400mg
Ivermectin
Ivermectin weight based dosing - max 21mg
Diethylcarbamazine
Diethylcarbamazine weight based dosing - max 500mg
Interventions
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Azithromycin
Treatment with Azithromycin single dose - weight based dosing max 2gm
Albendazole
Single dose of Albendazole weight based dosing
\- 400mg
Ivermectin
Ivermectin weight based dosing - max 21mg
Diethylcarbamazine
Diethylcarbamazine weight based dosing - max 500mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to give informed consent
Exclusion Criteria
* Hb \<7 at baseline
* Liver function or Creatinine \* 1.5 Upper Limit of Normal
* Urinary tract infection at baseline
* Pregnancy (female participants only)
* Routine medications which interact with study drugs
* Lactose/Gluten intolerance
* Permanent disability impeding study participation
18 Years
65 Years
ALL
Yes
Sponsors
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Lihir Medical Centre
OTHER
Responsible Party
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Oriol Mitja
Associate Professor
Locations
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Lihir Medical Centre
Londolovit, New Ireland Province, Papua New Guinea
Countries
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References
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Alshehri A, Chhonker YS, Bala V, Edi C, Bjerum CM, Koudou BG, John LN, Mitja O, Marks M, King CL, Murry DJ. Population pharmacokinetic model of ivermectin in mass drug administration against lymphatic filariasis. PLoS Negl Trop Dis. 2023 Jun 1;17(6):e0011319. doi: 10.1371/journal.pntd.0011319. eCollection 2023 Jun.
John LN, Bjerum C, Martinez PM, Likia R, Silus L, Wali C, Elizah A, Chhonker YS, Bala V, King CL, Murry DJ, Mitja O, Marks M. Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases. Clin Infect Dis. 2020 Aug 20:ciaa1202. doi: 10.1093/cid/ciaa1202. Online ahead of print.
Other Identifiers
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ComboNTDs-PK
Identifier Type: -
Identifier Source: org_study_id