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Table 1 Planned, ongoing or unpublished completed studies in the ICTRP as of 8 February 2023 evaluating small-molecule anti-infective drugs approved for human use but not included in current WHO recommended NTD strategies

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

WHO target

NTD

Source registry trial ID

Scientific title

Country of conduct

Registration datea

Statusb

Elimination

   

Onchocerciasis

   

 NCT02078024

ISRCTN50035143

Comparison of ivermectin alone with albendazole (ALB) plus ivermectin (IVM) in their efficacy against onchocerciasis in the Volta Region, Ghana

Ghana

20140228

(completed)

 NCT04188301

PACTR 201906665550709

Safety and efficacy of combination therapy with ivermectin, diethylcarbamazine, and albendazole (IDA) for individuals with onchocerciasis

Ghana

20191202

20190624

Active, not recruiting

 ISRCTN43697583

The efficacy of rifapentine 900 mg/d plus moxifloxacin 400 mg/d given for 14 or 7 days against onchocerciasis: a randomized, parallel-group, open-label, phase II pilot trial

Ghana

20150417

(completed)

 PACTR202212910949177

Exploiting the synergy of registered drugs rifampicin and albendazole to shorten the treatment duration of macrofilaricide for the cure of onchocerciasis in areas co-endemic with loiasis: an exploratory pilot phase II clinical trial study

Cameroon

20221219

(not yet recruiting, last follow-up December 2025)

 ISRCTN38954299

Assessment of the efficacy of 7-14 days treatment with either high dose rifampicin 35 mg/kg/day plus albendazole (400 mg/day), rifampicin 10 mg/kg/day plus albendazole (400 mg/d) or doxycycline 200 mg/day plus albendazole (400 mg/day) in the treatment of onchocerciasis: a randomized, controlled, parallel-group, open-label, phase II pilot trial Cameroon

Cameroon

20210604

Active, not recruiting, last follow-up May 2023)

 PACTR 202009704006025

The efficacy of rifampicin 35mg/kg/d plus albendazole 400mg/d given for 7 or 14 days against lymphatic filariasis and onchocerciasis: a randomized, controlled, parallel-group, open-label, phase II pilot trial

Ghana

20200713

Recruiting (last follow-up Dec. 2024)

Loiasis

   

 ISRCTN14889921

Pre-treatment of loiasis caused by the parasitic African eye worm Loa loa in Gabon with the antiparasitic medication albendazole among patients with a high risk of adverse events after another antiparasitic administration, ivermectin

Gabon

20221129 (retrospectively)

Projected completion February 2023

 PACTR201807197019027

Safety and efficacy of different albendazole-based treatment regimens to reduce microfilaraemia in subjects infected by Loa loa in an endemic area of Gabon: a randomised controlled open-label pilot study

[3 weeks albendazole 400mg bid vs. 3 weeks albendazole followed by 2 weeks albendazole vs.

3 weeks albendazole followed by a single dose of 150 µg/kg ivermectin as soon as microfilarial loads have dropped to < 4000 mf/ml in > 90% of subjects

vs. no treatment

Gabon

20180607

(retrospectively)

Completed

Elimination as public health problem

   

Chagas disease

   

 Registro Brasileira de Ensaios Clinicos ID: RBR-5n4htp

Disulfiram repurposing in the combined chemotherapy of Chagas disease—phase I/II clinical trial

Brazil

20200217

Recruiting

Lymphatic filariasis

   

 PACTR202009704006025

The efficacy of rifampicin 35mg/kg/d plus albendazole 400mg/d given for 7 or 14 days against lymphatic filariasis and onchocerciasis a randomized, controlled, parallel-group, open-label, phase II pilot trial

Ghana

20200713

Recruiting (last follow-up Dec. 2024)

 ISRCTN15320064

Comparing the effectiveness of test and treat approaches with doxycycline or the triple-drug therapy with ivermectin/diethylcarbamazine/albendazole vs. ivermectin/albendazole for targeted elimination of lymphatic filariasis in a phase III clinical trial

Ghana

20220,329

Not yet recruiting (last update August 2022)

Schistosomiasis

   

 NCT03893097

A proof-of-concept trial to evaluate artesunate-mefloquine as a novel alternative treatment for schistosomiasis in African children

Senegal

20190328

Completed

STH including strongyloidiasis

   

 PACTR202011642671155

An adaptive phase II/III single-blinded, randomized, multi-centre, parallel-group, active-controlled, superiority study to evaluate the safety and efficacy of a single day or 3-day single dose of an albendazole-ivermectin coformulation vs. albendazole for the treatment of soil-transmitted helminth infections (Trichuris trichiura, hookworm, Strongyloides stercoralis) in paediatric and young adult population

Kenya, Mozambique, Ethiopia

20201015

Recruiting

Last follow-up 31 July 2023

Control

   

Dengue

   

 NCT03432442

Pharmacokinetics and pharmacodynamics of ivermectin in pediatric dengue patients

Thailand

20180214

Completed (last update February 2021)

 CTRI/2021/09/036661

Role of doxycycline in the treatment of dengue infection

India

20210920

Not yet recruiting

(last update September 2021)

Buruli ulcer

   

 PACTR202209521256638

Shortening Buruli ulcer treatment: WHO recommended vs. a novel beta-lactam-containing therapy—phase III evaluation in West Africa [rifampicin plus clarithromycin (RC) for 8 weeks vs. RC plus amoxicillin/clavulanate for 4 weeks]

Ghana, Côte d’Ivoire, Togo

20220912

Planned start December 2022, planned final follow-up November 2023

Not yet recruiting

 NCT05169554

Beta-lactam containing regimen for the shortening of Buruli ulcer disease therapy: comparison of 8 weeks standard therapy (rifampicin plus clarithromycin) vs. 4 weeks standard plus amoxicillin/clavulanate therapy (RC8 vs. RCA4)

Benin

20211227

Recruiting, Primary outcome data November 2024

Cutaneous leishmaniasis

   

 IRCT20140211016554N4

Evaluation of the effectiveness of oral dapsone with intralesional antimoniate in treatment of cutaneous leishmaniasis in comparison with intralesional antimoniate alone

Islamic Republic of Iran

20190428

Completed

  1. aRegistration date provided as year month day. b Status as of source registry, accuracy of the status information depends on the timeliness with which sponsors update the source registry. If a study was registered in more than one registry, the most up-to-date status information at the time of writing of the manuscript is provided
  2. CTRI Clinical Trials Registry India, ICTRP WHO International Clinical Trials Registry Platform, ISRCTN registry managed by BMC, Springer Nature, NCT Clinical Trials.gov, PACTR Pan African Clinical Trial Registry, RBR Registro Brasileiro de Ensaios Clinicos